Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Biosearch Medical Products, Inc. · Predicate Candidate Screening

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

72 daysmedian FDA review time

191 days90th percentile

70clearances measured

K-number	Device	Applicant	Decided	Review days
K051480	ENTERAL FEEDING TUBE	Biosearch Medical Products, Inc.	2005-10-12	131
K970145	PERINEOMETER & VAGINAL PROBE (BIOFEEDBACK MONITOR #20 AND VA	Biosearch Medical Products, Inc.	1997-08-11	208
K964871	BIOSEARCH SYRING FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSC	Biosearch Medical Products, Inc.	1997-03-03	88
K951260	URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBR	Biosearch Medical Products, Inc.	1995-09-27	190
K944614	MEGA-BRUSH, ENDOSCOPIC MASS CYTOLOGY - CELLUAR RETRIEVAL SYS	Biosearch Medical Products, Inc.	1995-04-05	197
K932295	NON-BALLOON REPLACEMENT GASTROSTOMY KIT	Biosearch Medical Products, Inc.	1994-09-08	485
K935045	BIOSEARCH LAPROSCOPIC GASTRONOMY CATHETER	Biosearch Medical Products, Inc.	1994-08-19	302
K923002	ENTEROCLYSIS TUBE	Biosearch Medical Products, Inc.	1994-06-28	736
K934193	CELL-MATE(TM) MASS CYTOLOGY-CELLULAR RETRIEVAL SYST	Biosearch Medical Products, Inc.	1993-11-19	85
K922987	LAPSTICK LAPAROSCOPIC SPONGE STICK/ BLUNT DISSEC.	Biosearch Medical Products, Inc.	1993-04-23	305
K923474	LOW PROFILE GASTROMSTOMY DEVICE	Biosearch Medical Products, Inc.	1993-01-05	175
K922765	BIOSTARS STREP A OIA -- MODIFICATION	Biosearch Medical Products, Inc.	1992-08-20	79
K921029	DOBBHOFF BIPOLAR ADAPTER	Biosearch Medical Products, Inc.	1992-05-06	64
K913736	DOBBHOFF ANORECT BIOFEED SYST FIVE DIV FECAL CONST	Biosearch Medical Products, Inc.	1992-02-07	171
K915758	STREP A OIA	Biosearch Medical Products, Inc.	1992-01-30	38
K913784	DOBBHOFF(R) SINGLE PASS PEG KIT	Biosearch Medical Products, Inc.	1992-01-15	145
K914482	STOMA MEASURING DEVICE	Biosearch Medical Products, Inc.	1991-12-27	80
K912889	OIA STREP A	Biosearch Medical Products, Inc.	1991-10-31	122
K913073	DOBBHOFF(R) PERCUTANEOUS TRANSHEPAT BILIARY STENT	Biosearch Medical Products, Inc.	1991-10-25	106
K912129	DOBBHOFF(R) BIPOLAR HEMOSTATIC PROBE	Biosearch Medical Products, Inc.	1991-08-07	85
K903662	PEEWEE REPLACEMENT GASTROSTOMY TUBE	Biosearch Medical Products, Inc.	1990-12-12	121
K902843	BIOSEARCH ANAL BIOFEEDBACK DEVICE	Biosearch Medical Products, Inc.	1990-09-14	78
K902236	READS ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT	Biosearch Medical Products, Inc.	1990-08-14	89
K900324	DOBBHOFF WIRE GUIDED JEJUNAL FEEDING TUBE	Biosearch Medical Products, Inc.	1990-08-02	191
K900563	DOBBHOFF(R) ENDOENTERIC GASTRIC DECOMPRESSION CATH	Biosearch Medical Products, Inc.	1990-08-02	176
K900590	BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING	Biosearch Medical Products, Inc.	1990-08-02	176
K900624	DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING SYSTEM	Biosearch Medical Products, Inc.	1990-08-02	175
K901744	DOBBHOFF(R) RETRIEVAL FORCEPS	Biosearch Medical Products, Inc.	1990-07-03	77
K901582	DOBBHOFF BILIARY STENT SET	Biosearch Medical Products, Inc.	1990-06-22	79
K901322	DOBBHOFF(R) POLYPECTOMY SNARE	Biosearch Medical Products, Inc.	1990-06-15	86
K901924	READS(R) ANTI-ENA (SM/RNP) TEST KIT	Biosearch Medical Products, Inc.	1990-05-09	9
K901230	REAADS ANTI-SM TEST KIT	Biosearch Medical Products, Inc.	1990-03-23	9
K896612	DOBBHOFF(R) PAPILLOTOME	Biosearch Medical Products, Inc.	1990-02-12	83
K896518	DOBBHOFF(R) ERCP CANNULA	Biosearch Medical Products, Inc.	1990-02-02	79
K894857	PEDI-TUBE(R) STYLET	Biosearch Medical Products, Inc.	1989-10-03	64
K892444	REAADS-RF TEST KIT-QUANTITATIVE	Biosearch Medical Products, Inc.	1989-06-05	56
K892445	REAADS-RF TEST KIT-SEMIQUANTITATIVE	Biosearch Medical Products, Inc.	1989-06-05	56
K884309	NH PEDIATRIC REPLACEMENT GASTROSTOMY KIT	Biosearch Medical Products, Inc.	1988-12-08	56
K883587	BIOSEARCH 3600 ENTRI FEEDING PUMP	Biosearch Medical Products, Inc.	1988-11-08	77
K880232	NH REPLACEMENT GASTROSTOMY KIT	Biosearch Medical Products, Inc.	1988-03-03	43
K871528	ENTRIMIT GRAVITY FEEDING SET	Biosearch Medical Products, Inc.	1987-08-10	112
K864182	ENTERAL ADMINISTRATION ADAPTERS	Biosearch Medical Products, Inc.	1986-12-04	38
K854514	AMBI-24 PH/PRESSURE MONITOR	Biosearch Medical Products, Inc.	1986-02-24	104
K850664	ENDO-TUBE	Biosearch Medical Products, Inc.	1985-06-21	121
K850074	ESOPHOGEAL PH CATHETER	Biosearch Medical Products, Inc.	1985-02-14	36
K850134	ENTRON ENTERAL FEEDING BAG	Biosearch Medical Products, Inc.	1985-02-14	31
K844222	BIOSEARCH GLASER PEG PERCUTANEOUS ENDOSCOPIC GASTR	Biosearch Medical Products, Inc.	1984-12-05	34
K843168	ENTERAL FEEDING PUMP 14-800 SERIES	Biosearch Medical Products, Inc.	1984-10-24	72
K840936	NEEDLE CATHETER JEJUNOSTOMY REPAIR KIT	Biosearch Medical Products, Inc.	1984-03-22	17
K834268	ISLAMI GASTROINTESTINAL TUBE	Biosearch Medical Products, Inc.	1984-02-04	58

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