Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Smash Ent., Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K880857 | SYRINGE PUMP MS2000 | Smash Ent., Inc. | 1988-09-01 | 184 | 0 |
| K881162 | ENTERA* ENTERAL FEEDING BAG | Smash Ent., Inc. | 1988-06-03 | 77 | 0 |
| K880373 | IONOMETER E-HK AND ACCESSORIES | Smash Ent., Inc. | 1988-03-17 | 50 | 0 |
| K870183 | IONOMETER EF AND ACCESSORIES | Smash Ent., Inc. | 1987-05-12 | 116 | 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