Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biophotas, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
161 daysmedian FDA review time
268 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232977 | Biophotas Celluma CONTOUR | Biophotas, Inc. | 2023-11-21 | 61 | 0 |
| K211038 | Biophotas Celluma RESTORE | Biophotas, Inc. | 2021-06-29 | 83 | 0 |
| K171323 | BIOPHOTAS CELLUMA3 | Biophotas, Inc. | 2017-09-01 | 119 | 0 |
| K152280 | BioPhotas Celluma3 | Biophotas, Inc. | 2016-03-02 | 203 | 0 |
| K131113 | BIOPHOTAS CELLUMA | Biophotas, Inc. | 2014-01-15 | 268 | 0 |
| K122237 | BIOPHOTAS LIFELIGHT | Biophotas, Inc. | 2013-01-03 | 161 | 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