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

Sims Deltec, Inc. — Predicate Candidate Screening

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

81 daysmedian FDA review time

154 days90th percentile

32clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K010426	PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMB	Sims Deltec, Inc.	2001-03-08	23	0
K000842	CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM	Sims Deltec, Inc.	2000-06-08	85	2
K000942	CADD CHECKVALVE ADMINISTRATION SET, MODEL 21-7090	Sims Deltec, Inc.	2000-04-27	35	0
K994216	PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM	Sims Deltec, Inc.	2000-01-27	43	11
K992697	PORT-A-CATH II TRANS-ARTERIAL PERCUTANEOUS SYSTEM	Sims Deltec, Inc.	1999-11-18	99	0
K992880	P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEM	Sims Deltec, Inc.	1999-10-19	53	2
K991599	CADD ADMINISTRATION SET	Sims Deltec, Inc.	1999-06-15	36	32
K991301	CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER	Sims Deltec, Inc.	1999-06-09	54	1
K991255	CADD-TPN ADMINISTRATION SET, MODEL 21-7071	Sims Deltec, Inc.	1999-06-09	57	0
K990083	CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESE	Sims Deltec, Inc.	1999-02-12	32	0
K984055	CLINICATH POLYFLOW POLYURETHANE PERIPHERALLY INSERTED CATHET	Sims Deltec, Inc.	1999-01-29	77	0
K982838	CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400	Sims Deltec, Inc.	1998-11-04	84	2
K982839	CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300	Sims Deltec, Inc.	1998-11-02	82	0
K982836	CADD-LEGACY PLUS AMBULATORY INFUSION SYSTEM	Sims Deltec, Inc.	1998-11-02	82	0
K980583	EXTENSION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE CADD AD	Sims Deltec, Inc.	1998-04-27	69	0
K974661	0.2 U BACTERIAL FILTER	Sims Deltec, Inc.	1998-02-11	58	0
K974471	PORT-A-CATH- II DUAL-LUMEN LOW PROFILE SYSTEM, PORT-A-CATH I	Sims Deltec, Inc.	1998-01-22	57	3
K973917	CADD-DIPLOMAT PC COMMUNICATIONS SYSTEM AND THE CADD- AMBASSA	Sims Deltec, Inc.	1998-01-09	86	1
K973862	PORT-A-CATH LOW-PROFILE IMPLANTABLE ACCESS SYSTEMS	Sims Deltec, Inc.	1997-12-29	81	3
K974013	EXTENSION SET WITH MICROBORE TUBING, EXTENSION SET WITH MICR	Sims Deltec, Inc.	1997-12-17	56	0
K970269	CLINICATH IR PERIPHERALLY INSERTED CATHETER	Sims Deltec, Inc.	1997-06-26	154	0
K963009	DELTEC SUBCUTANEOUS INFUSION SET	Sims Deltec, Inc.	1996-10-18	77	0
K962695	PORT-A-CATH II VENOUS IMPLANTABLE ACCESS SYSTEMS PRECONNECTE	Sims Deltec, Inc.	1996-10-01	82	6
K961580	PORT-A-CATH P.A.S. PORT II IMPLANTABLE VENOUS ACCESS SYTEMS	Sims Deltec, Inc.	1996-09-20	149	0
K960826	CADD-PRIZM MODEL 6100 PUMP	Sims Deltec, Inc.	1996-08-23	176	1
K960957	EXTERNAL POWER SOURCE (EPS) SYSTEM, POWER PACK	Sims Deltec, Inc.	1996-06-04	85	0
K955180	CADD-PCA, -MICRO, -PRIZM AMBULATORY INFUSION PUMP	Sims Deltec, Inc.	1996-05-23	192	0
K955407	PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS	Sims Deltec, Inc.	1996-02-12	77	1
K954870	SIMS DELTEC ANTI-SIPHON VALVE	Sims Deltec, Inc.	1995-12-15	52	0
K935767	SIMS SILO NEEDLE DE-ACCESS ENCLOSURE	Sims Deltec, Inc.	1995-11-15	713	0
K951078	CATHETER, INTRAVASCULAR OR PERCUTANEOUS	Sims Deltec, Inc.	1995-07-31	144	0
K950284	SIMS DELTEC, INC. CATHETER REPLACEMENT CONNECTOR	Sims Deltec, Inc.	1995-05-23	119	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