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

Aesculap — Predicate Candidate Screening

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

91 daysmedian FDA review time

248 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days
K093649	AESCULAP STERILCONTAINER S	Aesculap	2010-05-11	167
K062085	S4 SPINAL SYSTEM	Aesculap	2007-03-02	224
K062510	AESCULAP STERILCONTAINER SYSTEM	Aesculap	2006-11-17	81
K061135	MINOP DISPOSABLE INTRODUCER 10F, MODEL ME010; 19F, MODEL ME0	Aesculap	2006-07-11	78
K043079	BICONTACT HIP SYSTEM WITH U-CAP	Aesculap	2004-12-08	30
K040865	AESCULAP STERRAD 100S COMPATABLE STERILCONTAINER	Aesculap	2004-12-06	248
K040191	BICONTACT HIP STEM AND FEMORAL HEAD	Aesculap	2004-08-25	210
K040864	CRANIOFIX AND CRANIOFIX2 TITANIUM CLAMP SYSTEM	Aesculap	2004-06-17	76
K031216	MONOPLUS POLY-P-DIOXANONE MONOFILAMENT ABSORBABLE SURGICAL S	Aesculap	2003-07-17	91
K031008	AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHIT	Aesculap	2003-05-09	39

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