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

Plasco, Inc. — Predicate Candidate Screening

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

84 daysmedian FDA review time

223 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days
K980066	CPR FILTERSHIELD	Plasco, Inc.	1998-07-16	190
K953414	CPR MICROMASK WITH OXYGEN INLET	Plasco, Inc.	1996-03-20	244
K951483	CPR MICROMASK	Plasco, Inc.	1995-10-19	203
K950770	CPR MICROSHIELD II	Plasco, Inc.	1995-03-10	17
K950769	CPR MICROMASK PLUS CATALOG NO 73-402	Plasco, Inc.	1995-03-10	17
K943386	CPR MICROMASK	Plasco, Inc.	1995-02-21	223
K932649	PHARMAFEED	Plasco, Inc.	1993-11-16	167
K880337	MACBICK DISPOSABLE BARIUM ENEMA SYST 4800 & 4700	Plasco, Inc.	1988-04-14	79
K870623	ENTERAL ADMINISTRATION SET	Plasco, Inc.	1987-06-26	134
K870019	THE LAHR BALLOON	Plasco, Inc.	1987-04-01	89
K870796	MACBICK-XL BASIC AIR CONTAST BARIUM ENEMA DELIV SY	Plasco, Inc.	1987-04-01	33
K831631	GASTROSTOMY FEEDING SET	Plasco, Inc.	1983-08-12	84
K832106	EXTERNAL INCONTINENCE CATHETER TRAVEL	Plasco, Inc.	1983-07-19	20
K832107	LEG BAG EXTENTION TUBE-STERILE	Plasco, Inc.	1983-07-19	20
K832109	EXTERNAL INCONTINENCE CATHETER TAKE-HOME	Plasco, Inc.	1983-07-18	19
K832108	EXTERNAL INCONTINENCE CATHETER SET-NON	Plasco, Inc.	1983-07-18	19

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