Physician Engineered Products, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Physician Engineered Products, Inc.” (first 1985, latest 2012), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 105 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 | 1 | 343 |
| 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 |
|---|---|---|---|
| LBI | Unit, Neonatal Phototherapy | 6 | 6 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 1 | 1 |
| FMS | Bed, Pediatric Open Hospital | 1 | 1 |
Review panels
- General Hospital (7)
- Anesthesiology (1)
Most recent Physician Engineered Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K110550 | BRIGHT EMBRACE MODEL SBL60 | LBI | 2012-02-03 | 343 |
| K093618 | BILI-MIRROR MODEL BLM-1 | LBI | 2010-04-23 | 151 |
| K974830 | ULTRA BILI LIGHT | LBI | 1998-05-20 | 147 |
| K883818 | MODIFIED REFLUX REDUCER | FMS | 1988-11-21 | 74 |
| K882291 | RETROFIT BABY FACE SHIELD (RFS) | LBI | 1988-06-20 | 19 |
| K882278 | RESUSCITATION BAG CONTROLLER (RBC) | BTM | 1988-06-16 | 15 |
| K873700 | INSTITUTIONAL BILI LIGHT (IBL) | LBI | 1987-12-11 | 88 |
| K850599 | HOME BILI LIGHTS-MODEL 100 | LBI | 1985-06-17 | 122 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2013-08-31.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Physician Industries, Inc. (4 510(k)s)
- Physician & Nurses Mfg. Corp. (1 510(k)s)
- Physician Software Systems, LLC (1 510(k)s)
- Physician Technologies, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Physician Engineered Products, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Physician Engineered Products, Inc.” (first 1985, latest 2012), across 3 product codes in 2 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 Physician Engineered Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Physician Engineered Products, Inc. is 105 days.
Which FDA product codes appear under Physician Engineered Products, Inc.?
The most frequent FDA product codes under this applicant name are LBI (Unit, Neonatal Phototherapy, 6); BTM (Ventilator, Emergency, Manual (Resuscitator), 1); FMS (Bed, Pediatric Open Hospital, 1).
Next steps
- See all 8 Physician Engineered Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LBI, Physician Engineered 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.