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

Spectramed, Inc. — Predicate Candidate Screening

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

112 daysmedian FDA review time

199 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K896122	AMNICATHDL(TM) DT-IUPC2 DUAL LUMEN TRANS. TIPPED	Spectramed, Inc.	1990-01-19	87	0
K892941	CCO SYSTEM MODEL SP1467,SP5567,SP6267	Spectramed, Inc.	1989-11-06	199	0
K895323	MODEL DT-BAL, BALANCE SAVER	Spectramed, Inc.	1989-10-24	56	0
K894362	MODEL DT-IUPC2 TRANSDUCER TIPPED DUAL LUMEN IUP	Spectramed, Inc.	1989-08-15	32	0
K881857	AMNICATH(TM) MODEL DT-IUPC TRANS. TIPPED INTRAU.	Spectramed, Inc.	1989-02-01	274	0
K885235	SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS.	Spectramed, Inc.	1989-01-25	36	1
K881825	MODELS SP5825/SP5835/SP5845/SP5855 PERCU. SHEATH	Spectramed, Inc.	1988-09-28	152	0
K875337	HEPARIN COATED LUMINAL PACING CATHETER	Spectramed, Inc.	1988-05-25	147	0
K880740	MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE	Spectramed, Inc.	1988-03-22	27	0
K873168	SPECTRAMED DISPOSABLE TRANSDUCER (DT-XXO) & ACCESS	Spectramed, Inc.	1988-01-12	154	0
K871573	CENTRAL VENOUS MULTI-LUMEN CATHETERS AND KITS	Spectramed, Inc.	1987-09-16	147	0
K865101	SPECTRAMED MODEL SP1455 HEMOPRO2 SYSTEM	Spectramed, Inc.	1987-04-20	111	0
K864507	V-PACE(TM) TRANSLUMINAL VENTRICULAR/ MODEL SP5540	Spectramed, Inc.	1987-03-06	112	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