Cayenne Medical, Inc.: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “Cayenne Medical, Inc.” (first 2006, latest 2019), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 89 days. Since 2017 the median was 49 days, against 90 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 5 | 91 |
| 2013 | 2 | 104 |
| 2014 | 0 | — |
| 2015 | 3 | 94 |
| 2016 | 1 | 112 |
| 2017 | 1 | 88 |
| 2018 | 1 | 49 |
| 2019 | 1 | 30 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Cayenne Medical, Inc. took a median 49 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 14 | 14 |
| HWC | Screw, Fixation, Bone | 6 | 6 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 3 | 3 |
Review panels
Most recent Cayenne Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K192428 | AFX Femoral Implant with Inserter | MBI | 2019-10-05 | 30 |
| K180274 | Ventix Link Knotless Anchor with Inserter | MBI | 2018-03-21 | 49 |
| K172186 | BioWick X Implant with Driver | MBI | 2017-10-16 | 88 |
| K161033 | AFX Femoral Implant With Inserter | MBI | 2016-08-03 | 112 |
| K151068 | SureLock W Suture Anchor | MBI | 2015-07-24 | 94 |
| K143473 | Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with needles, Short SureLock All-Suture Anchor, 1.4mm with (1) size 2-0 UHMWPE suture with needles | MBI | 2015-03-25 | 110 |
| K143392 | Quattro Bolt Tenodesis Screw | MBI | 2015-01-23 | 58 |
| K132867 | SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 1.4MM, SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 2.2MM | MBI | 2013-12-30 | 108 |
| K131325 | QUATTRO GL SUTURE ANCHOR | MBI | 2013-08-16 | 100 |
| K122314 | QUATRO LINK KNOTLESS ANCHOR WITH INSERTER, 2.9MM-PEEK ONLY | MBI | 2012-10-31 | 91 |
13 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2013-10-10.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Cayenne Medical, Inc.?
FDA lists 23 510(k) clearances under the applicant name “Cayenne Medical, Inc.” (first 2006, latest 2019), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Cayenne Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cayenne Medical, Inc. is 89 days. Since 2017: 49 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Cayenne Medical, Inc.?
The most frequent FDA product codes under this applicant name are MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 14); HWC (Screw, Fixation, Bone, 6); GAT (Suture, Nonabsorbable, Synthetic, Polyethylene, 3).
Next steps
- See all 23 Cayenne Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MBI, Cayenne Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.