Byron Medical: FDA filings under this applicant name
FDA lists 27 510(k) clearances under the applicant name “Byron Medical” (first 1986, latest 2004), across 16 product codes in 3 review panels. Median 510(k) review time under this name: 47 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 |
|---|---|---|---|
| FWP | Prosthesis, Chin, Internal | 4 | 4 |
| FRN | Pump, Infusion | 3 | 3 |
| FZE | Prosthesis, Nose, Internal | 3 | 3 |
| LZK | Implant, Malar | 3 | 3 |
| QPB | System, Suction, Lipoplasty For Removal | 3 | 3 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 | 1 |
| EFQ | Gauze/Sponge, Internal | 1 | 1 |
| EME | Punch, Biopsy, Surgical | 1 | 1 |
| GBA | Catheter, Balloon Type | 1 | 1 |
| GEA | Cannula, Surgical, General & Plastic Surgery | 1 | 1 |
Plus 6 more product codes.
Review panels
- General and Plastic Surgery (21)
- General Hospital (4)
- Dental (1)
Most recent Byron Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K040149 | PSI-TEC PERISTALTIC INFILTRATION PUMP | FRN | 2004-06-03 | 132 |
| K001803 | ACCELERATOR RECIPROCATING CANNULA | QPB | 2000-08-04 | 51 |
| K981215 | PSI-TEC LIPOSUCTION ASPIRATOR | QPB | 1998-07-01 | 90 |
| K981172 | LIPOPLASTY/ LIPOSUCTION ASPIRATION AND TUMESCENT INFUSION CANNULAE AND NEEDLES | QPB | 1998-06-30 | 90 |
| K980738 | PSI-TEC SYRINGE INFUSION PUMP AND ACCESSORIES FOR GENERAL FLUID IRRIGAION/INFILTRATION | FRN | 1998-06-16 | 111 |
| K980392 | PSI-TEC ASPIRATOR | BTA | 1998-03-05 | 31 |
| K974295 | BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING | KGZ | 1998-02-10 | 88 |
| K973133 | BIG BAG 3000 PRESSURE INFUSOR | FRN | 1997-09-12 | 22 |
| K934179 | DISPOSABLE BAG DECANTER | KPE | 1994-05-23 | 270 |
| K934233 | ZARA ZONE IV MALAR IMPLANT MODIFICATION | LZK | 1994-02-03 | 157 |
17 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Byron Medical.
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 Byron Medical (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 Byron Medical?
FDA lists 27 510(k) clearances under the applicant name “Byron Medical” (first 1986, latest 2004), across 16 product codes in 3 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 Byron Medical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Byron Medical is 47 days.
Which FDA product codes appear under Byron Medical?
The most frequent FDA product codes under this applicant name are FWP (Prosthesis, Chin, Internal, 4); FRN (Pump, Infusion, 3); FZE (Prosthesis, Nose, Internal, 3).
Next steps
- See all 27 Byron Medical clearances with predicates and recalls
- Run predicate analysis for product code FWP, Byron Medical'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.