Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

MSH — Predicate Candidate Screening

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

74 daysmedian FDA review time

184 days90th percentile

35clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K233022	Halyard Fluidshield 3 N95 Particulate Filter Respirator and	Owens & Minor (O&M) Halyard, Inc.	2024-01-12	112	0
K172963	Master-Frank N95 Particulate Respirator	Master & Frank Enterprise Co., Ltd.	2018-04-04	190	0
K171116	3M™ VFlex™ Health Care Particulate Respirator and Surgical M	3M Healthcare	2017-08-10	118	0
K160271	N95 Particulate Respirator and Surgical Mask, Models TN01-11	San-M Package Co., Ltd.	2016-07-15	164	0
K141876	Pasture F550S Surgical N95 Respirator, Pasture F550CS Surgic	Pasture Pharma Pte, Ltd.	2015-10-28	474	0
K121069	3M VFLEX HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MAS	3M Company	2013-02-11	308	0
K102923	BARRIER N95 PARTICULATE RESPIRATOR	Molnlycke Health Care	2010-11-19	49	0
K102092	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK,	Prestige Ameritech	2010-10-06	71	0
K102173	MOLDEX-METRIC HEALTH CARE N95 PARTICULATE RESPIRATOR AND SUR	Moldex/Metric, Inc.	2010-09-13	42	0
K100139	SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, MODELS B130 AND	Safelife Corp.	2010-05-04	105	0
K092824	N95 RESPIRATOR MASK, POSITIVE FACIAL LOCK WITH MAGIC ARCH, M	Alpha Protech, Inc.	2009-10-21	37	0
K090131	DS N95 SURGICAL MASKS AND FLAT SURGICAL	Shanghai Dasheng Health Products	2009-04-27	96	0
K080827	HANDAN N95 PARTICULATE RESPIRATORS AND SURGICAL MASK, MODELS	Handan Hengyong Protective & Clean Products Co., L	2008-04-04	10	0
K072067	N95 SURGICAL RESPIRATOR, TYPE AP0018 AND AP0028	Shuenn Bao Shing Corporation	2008-01-08	165	0
K072359	AEARO COMPANY SURGICAL N95 RESPIRATORS, MODELS N9508C AND N9	Aearo Company	2007-11-08	78	0
K070692	DUKAL N95PARTICULATE RESPIRATOR/SURGICAL FACE MASK	Dukal Corporation	2007-05-30	78	0
K070168	N95 RESPIRATOR, MODELS N9504C, N9504CS AND N9514C	Aearo Company	2007-04-18	90	0
K070782	WILLSON ONE-FIT FLAT-FOLD HEALTHCARE PARTICULATE RESPIRATOR	Survivair Respirators, LLC	2007-04-11	21	0
K070139	WILLSON ONE-FIT HEALTHCARE PARTICLE RESPIRATOR AND SURGICAL	Survivair, Inc.	2007-03-02	45	0
K063023	3M HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MOD	3M Company	2007-02-23	144	0
K063747	INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL	Inovel, LLC	2007-01-12	24	0
K063334	SHANGHAI GANGHAI MODEL GIKO 1400	Shanghai Gangkai Purifying Products Co., Ltd.	2006-12-08	32	0
K063013	PLEATS PLUS N95 RESPIRATOR, MODELS 1054 AND 1054S	Aearo Company	2006-12-01	60	0
K061375	RESPIRATOR N95 PARTICULATE RESPIRATOR, MODEL 1730	Louis M. Gerson Co., Inc.	2006-11-17	184	0
K062665	INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL	Inovel, LLC	2006-10-24	47	0
K062663	MOLDEX HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL	Moldex/Metric, Inc.	2006-10-11	34	0
K061859	INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS & SURGICAL MA	Inovel, LLC	2006-07-12	12	0
K051182	INOVEL HEALTH CARE MODEL N95 PARTICULATE RESPIRATORS AND SUR	Inovel, LLC	2005-05-19	10	1
K050193	GERSON 2130/31 TYPE N95 NIOSH CERTIFIED SURGICAL RESPIRATOR	Louis M. Gerson Co., Inc.	2005-04-11	74	0
K041855	PLEATS PLUS N95 PARTICULATE RESPIRATOR, MODELS 1050 AND 1050	Aearo Co.	2004-11-10	124	0
K042267	INOVEL HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL M	Inovel, LLC	2004-09-30	38	1
K020474	MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95	Makrite Industries, Inc.	2002-07-23	161	0
K974068	PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULA	Tecnol Medical Products, Inc.	1997-12-22	55	1
K970448	PCM 2000; ISOLAIR APR MODEL 2735	Tecnol Medical Products, Inc.	1997-04-30	83	0
K960778	ISOLAIR APR TYPE N95	Louis M. Gerson Co., Inc.	1996-05-09	73	0

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