Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TRACHEOSTOMY CARE KIT

K-Number: K921281 · 1992-08-27

ApplicantTrinity Laboratories, Inc.
Decision Date1992-08-27
Product CodeBTO
Advisory CommitteeAN
DecisionUnknown

Device Summary

TRACHEOSTOMY CARE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Trinity Laboratories, Inc.. It received FDA 510(k) clearance on 1992-08-27 under 510(k) number K921281. The device is classified under product code BTO. It was reviewed by the AN advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the TRACHEOSTOMY CARE KIT?

TRACHEOSTOMY CARE KIT is a medical device that received FDA 510(k) clearance on 1992-08-27. The listed applicant is Trinity Laboratories, Inc.. The 510(k) number is K921281.

When did TRACHEOSTOMY CARE KIT receive FDA 510(k) clearance?

TRACHEOSTOMY CARE KIT received FDA 510(k) clearance on 1992-08-27, under 510(k) number K921281.

Who is the listed applicant for TRACHEOSTOMY CARE KIT?

The FDA 510(k) record lists Trinity Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRACHEOSTOMY CARE KIT?

The FDA product code for TRACHEOSTOMY CARE KIT is BTO.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Trinity Laboratories, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K981441HEART CATH TRAY, STERILE, DISPOSABLEK974238DENTAL TRAY, STERILE, DISPOSABLEK974286CIRCUMCISION TRAY, CAT. NO. 70340K972160CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATION LATEX TESTK970722EYE TRAYK965201O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE

View all 44 devices →

Related Devices (Code: BTO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253063Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series)Vitaltec CorporationK2429215300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 5310600-5311000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Fenestrated, sizes 6.0-10.0mm; 5400600-5401000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, sizes 6.0-10.0mm; 5410500-5411000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, Fenestrated, sizes 6.0-10.0mmVitaltec CorporationK233713Pilling Tracheostomy TubesTeleflex MedicalK192511Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 9.0 mmVenner Medical (Singapore) Pte, Ltd.K173384BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tubeSmiths Medical Ads, Inc.K120079PRIMED TRACHEOSTOMY TUBES (MULTIPLE)Primed Halberstadt Medizintechnik GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑