Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

LGM — Predicate Candidate Screening

12 FDA 510(k) clearances under this product code; the 50 most recent screened below.

154 daysmedian FDA review time

379 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days
K231256	Carecube Negative Pressure Isolation Chamber	Carecubes, Inc.	2024-01-03	247
K163223	ORCA (tm) - Operational Rescue Containment Apparatus	Isovac Products, LLC	2017-11-02	351
K080117	PATIENT ISOLATION UNIT, MODEL G019-1000	Gentex Corporation	2009-01-30	379
K022260	FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS	Isolation Systems, Inc.	2002-08-29	62
K944133	MTB 1043 TREATMENT BOOTH	Mark Solutions, Inc.	1995-09-07	379
K912444	MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM	Radiometer America, Inc.	1992-02-18	260
K896721	MODEL 7-AT TREATMENT CHAMBER	J. H. Emerson Co.	1990-01-22	55
K884295	SURGICAL APPAREL, ISOLATION GOWN,MASK,CAP,SLEEVE	Saybrex Intl., Inc.	1988-11-08	27
K874306	INFECTIOUS DISEASE PROTECTION KIT, DISPOSABLE	Busse Hospital Disposables, Inc.	1988-03-22	154
K864116	ANAGO ISOLATION MASK (#80-950)	Anago, Inc.	1986-11-25	35
K831062	ISOLATION MASK I.C.S.	American Threshold Industries, Inc.	1983-04-13	5
K790657	STRETCHER TRANSIT ISOLATER #122	Vickers America Medical Corp.	1979-07-03	89

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda