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

Pharmacia Deltec, Inc. — Predicate Candidate Screening

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

97 daysmedian FDA review time

360 days90th percentile

43clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K943310	MODEL 6100 AMBULATORY INFUSION SYSTEM	Pharmacia Deltec, Inc.	1995-02-21	225	0
K942046	PHARMACIA DELTEC EXTENSION SET WITH ANTI-SIPHON VALVE	Pharmacia Deltec, Inc.	1994-10-04	159	0
K942161	LOCKBOX	Pharmacia Deltec, Inc.	1994-08-02	90	0
K942024	PORT-A-CATH LOW PROFILE IMPLANTABLE VENOUS ACCESS SYSTEM	Pharmacia Deltec, Inc.	1994-07-26	91	8
K941445	EXTENSION SET WITH ANTI-SIPHON VALVE	Pharmacia Deltec, Inc.	1994-06-29	97	0
K931073	CATH-FINDER	Pharmacia Deltec, Inc.	1994-05-05	429	4
K932433	PHERIPHERALLY INSERTED VENOUS CATHETER-Y SITE	Pharmacia Deltec, Inc.	1994-05-02	347	0
K932464	PERIPHERALLYINSRTED VENOUS CATH. ALTERNATE CATH.	Pharmacia Deltec, Inc.	1994-05-02	346	0
K932211	PROCEDURAL TRAY FOR PERIPHERALLY INSERTED VENOUS	Pharmacia Deltec, Inc.	1994-05-02	360	0
K932430	DUAL LUMEN PERIPHERALLY INSERTED VENOUS CATHETER	Pharmacia Deltec, Inc.	1994-05-02	347	0
K932198	PHARMACIA DELTEC PERIPHERALLY INSERTED VENOUS CATH	Pharmacia Deltec, Inc.	1994-05-02	361	0
K931113	CADD-TPN(TM) AMBULATORY INFUSION SYSTEM	Pharmacia Deltec, Inc.	1994-04-28	420	0
K926544	PHARMACIA DELTEC PERIPHERALLY INSERTED VENOUS CATH	Pharmacia Deltec, Inc.	1994-03-21	445	0
K933390	REMOTE RESERVOIR ADAPTER(TM) CASSETTE WITH BAG	Pharmacia Deltec, Inc.	1994-02-09	212	0
K932841	PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS ACCESS	Pharmacia Deltec, Inc.	1994-01-05	208	2
K932095	PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS ACCESS S	Pharmacia Deltec, Inc.	1994-01-05	250	1
K932840	PORT-A-CATH IMPLANTABLE VASCULAR ACCESS SYSTEM	Pharmacia Deltec, Inc.	1994-01-05	208	2
K931132	CADD-MICRO(TM) MODEL 5900 AMBULATORY INFUSION PUMP	Pharmacia Deltec, Inc.	1993-08-20	168	0
K923019	PHARMACIA DELTEC WINGED INFUSION SET	Pharmacia Deltec, Inc.	1993-04-21	302	0
K911791	CDD-PCA(TM) MODEL 5800R AMBULATORY INFUSION PUMP	Pharmacia Deltec, Inc.	1991-06-11	50	0
K904150	CATH-FINDER(TM) CATHETER TRACKING SYSTEM	Pharmacia Deltec, Inc.	1990-11-19	73	0
K904334	PERCUTANEOUS INTRAVENOUS CATHETER REPAIR KIT	Pharmacia Deltec, Inc.	1990-11-05	45	3
K903220	PORT-A-CATH IMPLANTABLE DRUG DELIVERY SYSTEM	Pharmacia Deltec, Inc.	1990-10-10	79	0
K902374	CADD-TPN MODEL 5700 AMBULATORY INFUSION SYSTEM	Pharmacia Deltec, Inc.	1990-09-14	107	0
K896075	CADD-PCA AMBULATORY INFUSION PUMPS	Pharmacia Deltec, Inc.	1990-08-21	306	0
K895644	CADD-PCA AMBULATORY INFUSION PUMPS	Pharmacia Deltec, Inc.	1990-08-08	322	0
K900888	LOCKBOX	Pharmacia Deltec, Inc.	1990-05-15	78	0
K896346	GRIPPER PORT-A-CATH NEEDLE WITH STOPCOCK	Pharmacia Deltec, Inc.	1990-01-18	76	0
K895712	PERCUTANEOUS INTRAVENOUS CATHETERS	Pharmacia Deltec, Inc.	1989-12-15	81	0
K895046	REMOTE RESERVOIR ADAPTER CASSETTE W/BAG SPIKE	Pharmacia Deltec, Inc.	1989-10-25	77	0
K890062	CADD-PCA MODEL 5800 AMBULATORY INFUSION PUMP	Pharmacia Deltec, Inc.	1989-03-23	73	0
K884701	CATH-FINDER SYSTEM	Pharmacia Deltec, Inc.	1989-02-01	84	0
K881690	PORT-A-CATH PORTAL INTRODUCER FORCEPS	Pharmacia Deltec, Inc.	1988-05-20	31	0
K881493	PORT-A-CATH IMPLANTABLE ACCESS SYSTEM - KIT CONF.	Pharmacia Deltec, Inc.	1988-05-20	42	0
K880204	CADD-TPA(TM) MODEL 5600 AMBULATORY INFUSION PUMP	Pharmacia Deltec, Inc.	1988-04-25	97	0
K875276	PORT-A-CATH(R) IMPLANTABLE DRUG DELIVERY SYSTEM	Pharmacia Deltec, Inc.	1988-04-13	111	0
K880072	PORT-A-CATH IMPLANTABLE DRUG DELIVERY SYSTEM	Pharmacia Deltec, Inc.	1988-03-29	78	0
K874649	CADD-PLUS(TM) MODEL 5400 AMBULATORY INFUSION PUMP	Pharmacia Deltec, Inc.	1988-01-19	67	0
K873885	PHARMACIA DELTEC SUBCUTANEOUS INFUSION SET	Pharmacia Deltec, Inc.	1987-11-03	41	0
K873042	MODEL 1330 EXTENSION SET	Pharmacia Deltec, Inc.	1987-10-23	80	0
K873876	PHARMACIA DELTEC BAG SPIKE SET	Pharmacia Deltec, Inc.	1987-10-23	31	0
K872821	INFUSION PUMP ENCLOSURE	Pharmacia Deltec, Inc.	1987-07-27	10	0
K870900	THE GRIPPER SEAL(TM)	Pharmacia Deltec, Inc.	1987-03-31	26	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