Sgarlato Laboratories, Inc.: FDA clearances and approvals
Sgarlato Laboratories, Inc. has 8 FDA 510(k) clearances (first 1989, latest 2005), across 6 product codes in 4 review panels. Median 510(k) review time: 157 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 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 |
|---|---|---|---|
| FRN | Pump, Infusion | 2 | 2 |
| KWH | Prosthesis, Toe, Constrained, Polymer | 2 | 2 |
| BXB | Exerciser, Powered | 1 | 1 |
| JDW | Pin, Fixation, Threaded | 1 | 1 |
| KQW | Goniometer, Nonpowered | 1 | 1 |
| MJW | Prosthesis, Subtalar, Plug, Polymer | 1 | 1 |
Review panels
- Orthopedic (4)
- General Hospital (2)
- Neurology (1)
- Physical Medicine (1)
Most recent Sgarlato Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K043204 | SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP | FRN | 2005-03-30 | 132 |
| K990101 | PAIN CONTROL INFUSION PUMP | FRN | 1999-03-19 | 66 |
| K982931 | THREADED FIXATION PIN | JDW | 1998-10-21 | 62 |
| K926262 | FIRST MPJ CONTINUOUS PASSIVE MOTION DEVICE | BXB | 1994-01-26 | 404 |
| K926237 | O'BRIEN GONIOMETER | KQW | 1993-08-02 | 234 |
| K922292 | LUNDEEN SUBTALAR PEG IMPLANT | MJW | 1992-10-23 | 161 |
| K905795 | SGARLATO FLEXIBLE HINGE TOE IMPLANT | KWH | 1991-05-29 | 153 |
| K884739 | SGARLATO LESSER TOE IMPLANT | KWH | 1989-05-18 | 185 |
Recalls
openFDA lists no recalls under a recalling firm named Sgarlato Laboratories, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Sgarlato Laboratories, Inc.'s product codes (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
Frequently asked questions
How many FDA 510(k) clearances does Sgarlato Laboratories, Inc. have?
Sgarlato Laboratories, Inc. has 8 FDA 510(k) clearances (first 1989, latest 2005), across 6 product codes in 4 review panels.
How long does FDA take to clear Sgarlato Laboratories, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Sgarlato Laboratories, Inc.'s cleared 510(k)s is 157 days.
What devices does Sgarlato Laboratories, Inc. make?
Its most frequent FDA product codes are FRN (Pump, Infusion, 2); KWH (Prosthesis, Toe, Constrained, Polymer, 2); BXB (Exerciser, Powered, 1).
Has Sgarlato Laboratories, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Sgarlato Laboratories, Inc. Related entities may recall under other names.
Next steps
- See all 8 Sgarlato Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FRN, Sgarlato Laboratories, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.