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

Amsco Co. — Predicate Candidate Screening

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

37 daysmedian FDA review time

130 days90th percentile

19clearances measured

K-number	Device	Applicant	Decided	Review days
K912471	EAGLE 3000 SDS	Amsco Co.	1992-06-26	388
K854922	AMSCO POLARIS SL	Amsco Co.	1986-01-24	45
K833187	HALL OSTEON	Amsco Co.	1983-10-31	42
K832945	EAGLE 2000 STERILIZER SERIES GAS/AERA	Amsco Co.	1983-10-19	50
K832186	HALL DRILL/REAMER	Amsco Co.	1983-08-12	37
K832188	HALL RECIPROCATOR	Amsco Co.	1983-08-12	37
K832187	HALL OSCILLATOR	Amsco Co.	1983-08-12	37
K831086	CEILING MOUNTED SUPPORT	Amsco Co.	1983-08-12	130
K831309	DELIVERY 4 TABLE	Amsco Co.	1983-06-15	54
K823360	SURGICAL LIGHT	Amsco Co.	1982-12-03	28
K811242	DISPOSABLE STERILIZATION WRAP	Amsco Co.	1981-05-21	17
K802838	STERNUM SAW BLADE	Amsco Co.	1980-12-11	29
K801737	STERNUM SAW	Amsco Co.	1980-08-20	26
K801109	PROOF (BIOLOGICAL/CHEMICAL INDICATOR)	Amsco Co.	1980-05-30	18
K782064	TABLE, EXAMINING-TWO EIGHTY	Amsco Co.	1978-12-28	15
K780771	MICRO RASPS	Amsco Co.	1978-05-16	11
K772135	BIOLOGICAL/CHEMICAL INDICATOR	Amsco Co.	1977-12-08	24
K761341	PORTAGAS AERATOR	Amsco Co.	1977-02-28	62
K761018	SURGICAL LIGHT - CHALLENGE 22 SERIES	Amsco Co.	1977-01-26	77

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