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)

SURE-LOK

K-Number: K021315 · 2002-08-21

ApplicantVital Signs, Inc.
Decision Date2002-08-21
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SURE-LOK is the device name listed in this FDA 510(k) record. The listed applicant is Vital Signs, Inc.. It received FDA 510(k) clearance on 2002-08-21 under 510(k) number K021315. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURE-LOK?

SURE-LOK is a medical device that received FDA 510(k) clearance on 2002-08-21. The listed applicant is Vital Signs, Inc.. The 510(k) number is K021315.

When did SURE-LOK receive FDA 510(k) clearance?

SURE-LOK received FDA 510(k) clearance on 2002-08-21, under 510(k) number K021315.

Who is the listed applicant for SURE-LOK?

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

What is the FDA product code for SURE-LOK?

The FDA product code for SURE-LOK is FMI.

Other records listing Vital Signs, 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.

K112902ENFLOW IV FLUID WARMERK041309IMASK TMK030985BREAS PV 10I CPAP SYSTEM, MODEL PV 10IK022402DISPOSABLE PRESSURE MANOMETERK002454BREAS HA50 HUMIDIFIER, MODEL HA50K001553BREAS PV 100 CPAP SYSTEM

View all 75 devices →

Related Devices (Code: FMI)

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.

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHDK261719Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)Hh Global Technology, Inc.K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd.

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.

↑