Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

LWH — Predicate Candidate Screening

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

56 daysmedian FDA review time

167 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K121274	PIXEL APP	Gauss Surgical, Inc.,	2012-06-27	61	0
K120473	PIXEL APP	Gauss Surgical, Inc.,	2012-04-09	53	0
K100551	ORLOCATE SYSTEM MODEL ORL 100	Haldor Advanced Technologies, Ltd.	2010-08-12	167	0
K093557	SMARTWAND-DTX	Clearcount Medical Solutions	2009-12-18	32	0
K073180	SMARTSPONGE PLUS SYSTEM	Clearcount Medical Solutions, Inc.	2007-11-19	6	0
K071355	SMARTSPONGE SYSTEM	Clearcount Medical Solutions, Inc.	2007-05-24	9	0
K062642	RF SURGICAL SYSTEMS INC. DETECTION SYSTEM, MODEL 100A	Rf Surgical Systems, Inc.	2006-11-02	57	0
K061316	MEDLINE SURGICAL SPONGE SCANNER	Medline Industries, Inc.	2006-11-02	175	1
K060076	SURGICOUNT SAFETY-SPONGE SYSTEM	Surgicount Medical	2006-03-14	63	2
K982260	MARKWELL GAUZE SPONGE	Markwell Intl., Inc.	1998-08-12	47	0
K972302	POCKET COUNT OR SAFETCOUNT	Sage Products, Inc.	1997-07-25	36	0
K945144	SPONGE COUNT	Michael Fischer Assoc.	1995-01-12	84	0
K912824	DEVON SPONGE COUNTER BAGS	Devon Industries, Inc.	1991-08-26	61	0
K873555	GORSK SPONGE CONTAINMENT SYSTEM	Gorsk, Inc.	1987-10-23	56	0
K790538	SPONGE COUNTER	Devon Industries, Inc.	1979-04-04	15	0

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