Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sgarlato Laboratories, Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
161 daysmedian FDA review time
404 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K043204 | SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP | Sgarlato Laboratories, Inc. | 2005-03-30 | 132 | 0 |
| K990101 | PAIN CONTROL INFUSION PUMP | Sgarlato Laboratories, Inc. | 1999-03-19 | 66 | 0 |
| K982931 | THREADED FIXATION PIN | Sgarlato Laboratories, Inc. | 1998-10-21 | 62 | 0 |
| K926262 | FIRST MPJ CONTINUOUS PASSIVE MOTION DEVICE | Sgarlato Laboratories, Inc. | 1994-01-26 | 404 | 0 |
| K926237 | O'BRIEN GONIOMETER | Sgarlato Laboratories, Inc. | 1993-08-02 | 234 | 0 |
| K922292 | LUNDEEN SUBTALAR PEG IMPLANT | Sgarlato Laboratories, Inc. | 1992-10-23 | 161 | 0 |
| K905795 | SGARLATO FLEXIBLE HINGE TOE IMPLANT | Sgarlato Laboratories, Inc. | 1991-05-29 | 153 | 1 |
| K884739 | SGARLATO LESSER TOE IMPLANT | Sgarlato Laboratories, Inc. | 1989-05-18 | 185 | 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