Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Physician Engineered Products, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
122 daysmedian FDA review time
343 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K110550 | BRIGHT EMBRACE MODEL SBL60 | Physician Engineered Products, Inc. | 2012-02-03 | 343 | 1 |
| K093618 | BILI-MIRROR MODEL BLM-1 | Physician Engineered Products, Inc. | 2010-04-23 | 151 | 0 |
| K974830 | ULTRA BILI LIGHT | Physician Engineered Products, Inc. | 1998-05-20 | 147 | 0 |
| K883818 | MODIFIED REFLUX REDUCER | Physician Engineered Products, Inc. | 1988-11-21 | 74 | 0 |
| K882291 | RETROFIT BABY FACE SHIELD (RFS) | Physician Engineered Products, Inc. | 1988-06-20 | 19 | 0 |
| K882278 | RESUSCITATION BAG CONTROLLER (RBC) | Physician Engineered Products, Inc. | 1988-06-16 | 15 | 0 |
| K873700 | INSTITUTIONAL BILI LIGHT (IBL) | Physician Engineered Products, Inc. | 1987-12-11 | 88 | 0 |
| K850599 | HOME BILI LIGHTS-MODEL 100 | Physician Engineered Products, Inc. | 1985-06-17 | 122 | 0 |
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