Biosearch Medical Products, Inc.: FDA filings under this applicant name
FDA lists 70 510(k) clearances under the applicant name “Biosearch Medical Products, Inc.” (first 1978, latest 2005), across 23 product codes in 8 review panels. Median 510(k) review time under this name: 69 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | 35 | 35 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 3 | 3 |
| FRN | Pump, Infusion | 3 | 3 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 3 | 3 |
| DHR | System, Test, Rheumatoid Factor | 2 | 2 |
| FAP | Cystometric Gas (Carbon-Dioxide) On Hydraulic Device | 2 | 2 |
| FFT | Electrode, Ph, Stomach | 2 | 2 |
| FPD | Tube, Feeding | 2 | 2 |
| FZX | Guide, Surgical, Instrument | 2 | 2 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 2 | 2 |
Plus 13 more product codes.
Review panels
- Gastroenterology and Urology (53)
- General Hospital (4)
- Immunology (4)
- Microbiology (3)
- General and Plastic Surgery (3)
- Ear, Nose and Throat (1)
- Hematology (1)
- Neurology (1)
Most recent Biosearch Medical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K051480 | ENTERAL FEEDING TUBE | BSS | 2005-10-12 | 131 |
| K970145 | PERINEOMETER & VAGINAL PROBE (BIOFEEDBACK MONITOR #20 AND VAGINAL PROBE) | HIR | 1997-08-11 | 208 |
| K964871 | BIOSEARCH SYRING FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTS | FEB | 1997-03-03 | 88 |
| K951260 | URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANT | KOD | 1995-09-27 | 190 |
| K944614 | MEGA-BRUSH, ENDOSCOPIC MASS CYTOLOGY - CELLUAR RETRIEVAL SYSTEM | FDX | 1995-04-05 | 197 |
| K932295 | NON-BALLOON REPLACEMENT GASTROSTOMY KIT | KNT | 1994-09-08 | 485 |
| K935045 | BIOSEARCH LAPROSCOPIC GASTRONOMY CATHETER | KNT | 1994-08-19 | 302 |
| K923002 | ENTEROCLYSIS TUBE | KNT | 1994-06-28 | 736 |
| K934193 | CELL-MATE(TM) MASS CYTOLOGY-CELLULAR RETRIEVAL SYST | EOX | 1993-11-19 | 85 |
| K922987 | LAPSTICK LAPAROSCOPIC SPONGE STICK/ BLUNT DISSEC. | GCJ | 1993-04-23 | 305 |
60 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Biosearch Medical Products, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Biosearch Medical Products, Inc. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
Frequently asked questions
How many FDA 510(k) clearances are listed under Biosearch Medical Products, Inc.?
FDA lists 70 510(k) clearances under the applicant name “Biosearch Medical Products, Inc.” (first 1978, latest 2005), across 23 product codes in 8 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Biosearch Medical Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biosearch Medical Products, Inc. is 69 days.
Which FDA product codes appear under Biosearch Medical Products, Inc.?
The most frequent FDA product codes under this applicant name are KNT (Tubes, Gastrointestinal (And Accessories), 35); FGE (Stents, Drains And Dilators For The Biliary Ducts, 3); FRN (Pump, Infusion, 3).
Next steps
- See all 70 Biosearch Medical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KNT, Biosearch Medical Products, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.