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

Gebauer Co. — Predicate Candidate Screening

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

202 daysmedian FDA review time

1181 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K032671	GEBAUER'S SKIN REFRIGERANT (MIST STREAM), GEBAUER'S SKIN REF	Gebauer Co.	2004-03-17	201	3
K031036	GEBAUER'S SKIN REFRIGERANT (MIST SPRAY), MODEL P/N 0386-0010	Gebauer Co.	2003-07-10	100	1
K021726	GEBAUER'S INSTANT ICE	Gebauer Co.	2002-12-12	202	2
K981693	SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART	Gebauer Co.	2001-08-06	1181	2
K002596	GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09	Gebauer Co.	2001-02-15	178	1
K001624	GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04	Gebauer Co.	2001-01-25	244	0
K991514	GEBAUER'S CHLORIDE FINE NOZZE	Gebauer Co.	1999-07-16	77	0
K930915	FLUORI METHANE SS- A VAPOCOOLANT/SKIN REF. DEVICE	Gebauer Co.	1994-09-29	583	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