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

Ormed Mfg., Inc. — Predicate Candidate Screening

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

27 daysmedian FDA review time

139 days90th percentile

23clearances measured

K-number	Device	Applicant	Decided	Review days
K931555	ARTROMOT K2 CPM	Ormed Mfg., Inc.	1994-01-31	307
K882529	BUTCHER STRUNG TONSIL SPONGE	Ormed Mfg., Inc.	1988-07-18	27
K882527	GAUZE SPONGE	Ormed Mfg., Inc.	1988-07-18	27
K882528	CYLINDRICAL SPONGE	Ormed Mfg., Inc.	1988-07-18	27
K882530	TAPE STRUNG TONSIL SPONGE	Ormed Mfg., Inc.	1988-07-18	27
K880853	CHERRY SPONGE	Ormed Mfg., Inc.	1988-03-17	16
K880851	FLAT STICK SPONGE	Ormed Mfg., Inc.	1988-03-17	16
K880907	TRIANGLE SPONGE	Ormed Mfg., Inc.	1988-03-17	14
K880852	ROSEBUD DISSECTORS	Ormed Mfg., Inc.	1988-03-17	16
K880910	ROUND STICK SPONGES	Ormed Mfg., Inc.	1988-03-17	14
K880909	TRACHEOTOMY SPONGES	Ormed Mfg., Inc.	1988-03-17	14
K880911	BLUNT SPONGE	Ormed Mfg., Inc.	1988-03-17	14
K880854	STRUNG ABSORBENT BALLS	Ormed Mfg., Inc.	1988-03-17	16
K873831	EAR AND EYE SPONGES	Ormed Mfg., Inc.	1987-10-05	14
K873391	MODIFIED ROUND (BEEHIVE) DISSECTOR 3/8	Ormed Mfg., Inc.	1987-09-11	18
K852202	STRUNG NEURO SPONGE PATTIES, X-RAY OPAGUE	Ormed Mfg., Inc.	1985-06-26	36
K831936	PRE-ROLLED TUBULAR STOCKINETTE	Ormed Mfg., Inc.	1983-12-30	198
K831914	STRUNG NEURO SPONGE PATTIES-X-RAY-	Ormed Mfg., Inc.	1983-10-31	139
K831912	ROUND-BEEHIVE- DISSECTORS 3/8	Ormed Mfg., Inc.	1983-10-31	139
K831913	COLOR-EZE PRE-WASHED LAP SPONGES	Ormed Mfg., Inc.	1983-09-26	104
K832047	STERILE SUTURE REMOVAL SET	Ormed Mfg., Inc.	1983-09-12	80
K831911	DISPOSABLE FLOOR INSTRUMENTS	Ormed Mfg., Inc.	1983-09-12	90
K831915	SAFETY PINS & RUBBER BANDS	Ormed Mfg., Inc.	1983-09-12	90

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