Atlas FDA

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

Aesculap Instruments Corp. — Predicate Candidate Screening

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

36 daysmedian FDA review time
406 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K885046INSITUCAT VALVE STRIPPERAesculap Instruments Corp.1990-02-284500
K890182PROTEGRAFT DV 1500, 1900 & LOW POR, UNIGRAFT DVAesculap Instruments Corp.1990-02-284060
K890443CASPAR SCALP CLIP, APPLIERAesculap Instruments Corp.1989-06-151390
K893121ROBOTRAC (TM) RETRACTOR ARMAesculap Instruments Corp.1989-06-01370
K884057ELAN-E DISPOSABLE DRAPEAesculap Instruments Corp.1988-10-19230
K880704CERULLO SUCTION REGULATORAesculap Instruments Corp.1988-03-29360
K860016AESCULAP BONE MILLAesculap Instruments Corp.1986-03-19750
K801886BURR, DENTALAesculap Instruments Corp.1980-08-20230
K801888HANDPIECE, DENTALAesculap Instruments Corp.1980-08-20230
K801887DRILL, DENTALAesculap Instruments Corp.1980-08-20230
K792558CONTAINER SYSTEMAesculap Instruments Corp.1979-12-27150
K781343RESURFACE PROSHESISAesculap Instruments Corp.1978-09-27540
K772200YASARGIL ANEURYSM CLIPSAesculap Instruments Corp.1977-12-0890

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