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

Cp Medical · Predicate Candidate Screening

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

73 daysmedian FDA review time

200 days90th percentile

31clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K094028	CP-FIBER (ORTHOFIBER)	Cp Medical	2010-03-18	78	0
K072229	MONOSWIFT	Cp Medical	2007-10-05	56	0
K071550	PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS	Cp Medical	2007-07-18	42	0
K060987	OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31	Cp Medical	2006-11-02	206	0
K041894	ORTHOFIBER	Cp Medical	2004-09-17	66	0
K034062	CP SLEEVE AND RIVER SLEEVE	Cp Medical	2004-01-30	30	0
K024372	CP MEDICAL BONE WAX	Cp Medical	2003-06-19	170	0
K030786	MONO-SWIFT	Cp Medical	2003-05-06	55	1
K030351	STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLE	Cp Medical	2003-03-28	53	0
K023710	VISORB SWIFT	Cp Medical	2003-01-17	74	0
K022075	DISPOSABLE TEMPORARY PACING CABLE,MODELS CPW-BV-5,CPW-LG-5,C	Cp Medical	2002-09-19	85	0
K021311	SYNTHETIC ABSORBABLE SEEDING SPACERS MADE OF POLYDIOXANONE M	Cp Medical	2002-07-13	79	0
K013975	CP-SLEEVE	Cp Medical	2002-02-22	81	0
K013964	MODIFICATION TO ACCU-SPACE PLAIN GUT ABSORBABLE SEEDING SPAC	Cp Medical	2002-01-24	52	0
K013274	MONO-DOX, SYNTHETIC ABSORBABLE POLYDIOXANONE SURGICAL SUTURE	Cp Medical	2001-11-16	46	3
K010621	ACCU-SPACE ABSORBABLE SEEDING SPACERS	Cp Medical	2001-09-04	187	0
K002190	POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE (USP)	Cp Medical	2000-08-10	21	1
K001173	NYLON, NONABSORBABLE SURGICAL SUTURES USP	Cp Medical	2000-06-23	73	1
K001185	POLYPROPYLENE, NONABSORBABLE SURGICAL SUTURES USP	Cp Medical	2000-06-23	73	1
K001184	SILK, NONABSORBABLE, SURGICAL SUTURES, USP	Cp Medical	2000-06-23	73	0
K001299	PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USP	Cp Medical	2000-06-23	60	0
K001172	POLYESTER NONABSORBABLE SURGICAL SUTURES URP	Cp Medical	2000-06-23	73	1
K911230	RS-1000	Cp Medical	1993-06-09	812	0
K913337	INJECTION CAP	Cp Medical	1992-02-11	200	0
K911118	DTF-1000LL,DTF-1000	Cp Medical	1991-11-20	253	0
K854006	PLASTELAST AND/OR ELASTOPLASTE	Cp Medical	1985-11-25	56	0
K853536	VELCRO FISTULA PRESSURE CLAMPS	Cp Medical	1985-10-17	55	0
K853538	CANNULA CLAMP	Cp Medical	1985-09-12	20	0
K853537	VELCRO TOURNIQUET	Cp Medical	1985-09-12	20	0
K840654	DIALYSIS ADMIN. SET - I.V.	Cp Medical	1984-05-02	77	0
K821268	TRANSDUCER FILTER	Cp Medical	1982-06-23	51	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