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

Hgm, Inc. — Predicate Candidate Screening

23 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

69 daysmedian FDA review time

280 days90th percentile

23clearances measured

K-number	Device	Applicant	Decided	Review days
K950120	SMART PLUG	Hgm, Inc.	1995-08-11	211
K931072	HGM ILLUMINATING/ASPIRATING ENDOOCULAR PROBE	Hgm, Inc.	1994-11-10	618
K931784	HGM ILLUMINATING IMAGING ENDOCULAR PROBE	Hgm, Inc.	1994-03-01	326
K933333	HGM SCANMAN PLUS	Hgm, Inc.	1993-09-23	77
K931499	Q-11 OPHTHALMIC LASER	Hgm, Inc.	1993-08-19	147
K925663	HGM ASPIRATING ENDOOCULAR(TM) PROBE	Hgm, Inc.	1993-08-17	280
K930543	E-25 KRYPTON ION LASER (SURGICA K5)	Hgm, Inc.	1993-06-22	140
K880908	MODEL PC ARGON LASER	Hgm, Inc.	1988-05-03	61
K873773	ENDOCOAGULATOR MODELS 8 AND 20 ARGON LASER	Hgm, Inc.	1987-10-13	27
K872630	ENDOCOAGULATOR(TM) MODEL 20 ARGON LASER FOR UROLO.	Hgm, Inc.	1987-08-25	50
K870773	ENDOCOAGULATOR MODELS 5, 8 & 20 ARGON LASER	Hgm, Inc.	1987-07-10	134
K871424	ENDOCOAGULATOR MODEL 5, 8 & 20 ARGON LASER	Hgm, Inc.	1987-07-08	90
K862227	MODEL 8 & 20 ARGON LASER FOR PELVIC SURGERY IN GYN	Hgm, Inc.	1986-08-19	69
K860357	HGM, INC. LASERCATH (STERILE)	Hgm, Inc.	1986-04-07	67
K860358	FLEISCHMAN-SWARTZ ENDO-OCULAR PROBE (STERILE)	Hgm, Inc.	1986-03-21	50
K852913	HGM ENDOCOAGULATOR MODEL 20	Hgm, Inc.	1985-09-05	56
K851651	HGM ENDOCOAGULATOR MODEL 8	Hgm, Inc.	1985-07-23	92
K850572	HGM, INC. MEDICAL LASER ENDOCOAGULATOR MODEL 8-K	Hgm, Inc.	1985-04-23	69
K840590	FLEISCHMAN-SWARTZ ENDO-OCULAR PROBE	Hgm, Inc.	1984-05-09	90
K840854	MEDICAL LASER ENDOCOAGULATOR 5K	Hgm, Inc.	1984-04-02	38
K837422	LASER PHOTOCOAGULATOR	Hgm, Inc.	1983-06-10	49
K837306	LASER PHOTOCOAGULATOR	Hgm, Inc.	1983-04-21	31
K827847	ARGON FIBER OPTIC CATHETER	Hgm, Inc.	1983-01-03	60

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