Influence, Inc.: FDA clearances and approvals
Influence, Inc. has 16 FDA 510(k) clearances (first 1996, latest 1999), across 8 product codes in 4 review panels. Median 510(k) review time: 72 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 |
|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 5 | 5 |
| GEH | Unit, Cryosurgical, Accessories | 2 | 2 |
| HXJ | Staple Driver | 2 | 2 |
| LRK | Device, Anti-Snoring | 2 | 2 |
| OTN | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | 2 | 2 |
| FEN | Device, Cystometric, Hydraulic | 1 | 1 |
| FZP | Clip, Implantable | 1 | 1 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
Review panels
Most recent Influence, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K981677 | REPOSE BONE SCREW SYSTEM | LRK | 1999-08-27 | 472 |
| K991792 | CRYO-MONO CRYOGENIC SYSTEM, MODEL CRYO-MONO WITH TUF PROBE | GEH | 1999-08-12 | 78 |
| K992277 | STAPLETAC BONE ANCHOR SYSTEM | HWC | 1999-07-30 | 23 |
| K991122 | CRYO-MONO CRYOGRNIC SYSTEM | GEH | 1999-07-01 | 90 |
| K990160 | MICROTAC-BONE ANCHOR SYSTEM | MBI | 1999-02-16 | 28 |
| K990095 | STRAIGHT-IN-ORTHOPEDIC BONE SCREW FIXATION SYSTEM | MBI | 1999-02-01 | 20 |
| K983325 | IN-PROBE II URODYNAMIC SYSTEM | FEN | 1998-11-24 | 63 |
| K982155 | SHORT STRAIGHT-IN BONE SCREW FIXATION SYSTEM | MBI | 1998-08-31 | 74 |
| K981631 | INFLUENCE CLIP SYSTEM | FZP | 1998-07-28 | 82 |
| K980482 | TRIANGLE SLING | OTN | 1998-03-27 | 46 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Influence, 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.
Frequently asked questions
How many FDA 510(k) clearances does Influence, Inc. have?
Influence, Inc. has 16 FDA 510(k) clearances (first 1996, latest 1999), across 8 product codes in 4 review panels.
How long does FDA take to clear Influence, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Influence, Inc.'s cleared 510(k)s is 72 days.
What devices does Influence, Inc. make?
Its most frequent FDA product codes are MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 5); GEH (Unit, Cryosurgical, Accessories, 2); HXJ (Staple Driver, 2).
Has Influence, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Influence, Inc. Related entities may recall under other names.
Next steps
- See all 16 Influence, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MBI, Influence, 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.