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

GFD — Predicate Candidate Screening

12 FDA 510(k) clearances under this product code; the 50 most recent screened below.

41 daysmedian FDA review time

115 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days
K965256	DMS-1000C DERMOABRADER	Mattioli Engineering, Srl	1996-12-09	115
K962371	DERMTOME BLADE	Dsp Worldwide	1996-08-29	71
K945594	DECA DERMATOME (MICROMOTOR SYSTEM)	Depuy Intl., Ltd.	1995-06-05	203
K951085	PADGETT AIR DERMATOME, MODEL A	Padgett Instruments, Inc.	1995-05-15	67
K940208	AESCULAP ACCU-DERMATOME	Aesculap, Inc.	1994-02-24	41
K862669	ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST	U. S. Diagnostics, Inc.	1986-10-03	81
K861285	SKIN MESH DEVICE	Precision Modified Devices	1986-04-17	10
K861138	MASH DERMATOME	Mecron Medical Products, Inc.	1986-04-14	19
K860925	DERMASPANDERE	Mri Ventures, Inc.	1986-03-28	17
K842702	ROSENBERG SKIN GRAFTING KNIVES	Downs Surgical , Ltd.	1984-08-02	22
K830993	AMPLIGREFFE	Prothia USA, Inc.	1983-05-03	35
K792332	DAVOL/SIMON DERMATOME	Davol, Inc.	1979-12-06	17

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