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)

Consolidated HC Steam Sterilizer

K-Number: K220736 · 2022-08-01

ApplicantConsolidated Machine Corp.
Decision Date2022-08-01
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Consolidated HC Steam Sterilizer is the device name listed in this FDA 510(k) record. The listed applicant is Consolidated Machine Corp.. It received FDA 510(k) clearance on 2022-08-01 under 510(k) number K220736. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Consolidated HC Steam Sterilizer?

Consolidated HC Steam Sterilizer is a medical device that received FDA 510(k) clearance on 2022-08-01. The listed applicant is Consolidated Machine Corp.. The 510(k) number is K220736.

When did Consolidated HC Steam Sterilizer receive FDA 510(k) clearance?

Consolidated HC Steam Sterilizer received FDA 510(k) clearance on 2022-08-01, under 510(k) number K220736.

Who is the listed applicant for Consolidated HC Steam Sterilizer?

The FDA 510(k) record lists Consolidated Machine Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Consolidated HC Steam Sterilizer?

The FDA product code for Consolidated HC Steam Sterilizer is FLE.

Related Devices (Code: FLE)

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.

K261055AMSCO 700 Steam SterilizerSTERIS CorporationK260254Enbio PROEnbio Group AGK252307Getinge GSS67N Series Steam SterilizerMaquet GmbH (A Getinge Group Company)K250168Life Ultra 25L Tabletop Mono Chamber Steam SterilizerLucas LifecareK250164Cassette Autoclave (ACA5)Guangzhou Ajax Medical Equipment Co., Ltd.K243994Steam Sterilizer (2545D)Ningbo Ican Machines Co., 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.

↑