Instylla, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Instylla, Inc.” (first 2019, latest 2026), plus 1 PMA decision, across 4 product codes in 2 review panels. Median 510(k) review time under this name: 38 days. Since 2017 the median was 38 days, against 154 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 |
|---|---|---|
| 2019 | 2 | 78 |
| 2020 | 1 | 29 |
| 2021 | 2 | 78 |
| 2022 | 1 | 85 |
| 2023 | 0 | — |
| 2024 | 1 | 262 |
| 2025 | 2 | 26 |
| 2026 | 1 | 28 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Instylla, Inc. took a median 38 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 154 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FMF | Syringe, Piston | 4 | 4 |
| KRA | Catheter, Continuous Flush | 4 | 4 |
| KRD | Device, Vascular, For Promoting Embolization | 2 | 2 |
| QVG | Embolization Agent, Vascular | 1 | 0 |
Review panels
- Cardiovascular (7)
- General Hospital (4)
Most recent Instylla, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261610 | Verge Microcatheter | KRA | 2026-06-11 | 28 |
| K253769 | Instylla Delivery Kit | FMF | 2025-12-22 | 27 |
| K253677 | Tembo Embolic System | KRD | 2025-12-15 | 24 |
| K240873 | TEMBO Embolic System | KRD | 2024-12-16 | 262 |
| K213632 | Instylla Delivery Kit | FMF | 2022-02-10 | 85 |
| K210808 | Instylla Microcatheter 1.2 | KRA | 2021-04-15 | 29 |
| K202544 | Instylla Delivery Kit | FMF | 2021-01-07 | 127 |
| K200744 | Instylla Microcatheter | KRA | 2020-04-21 | 29 |
| K191659 | Instylla Delivery Kit | FMF | 2019-10-10 | 111 |
| K191731 | Instylla Microcatheter | KRA | 2019-08-13 | 46 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P250003 | PMA | Embrace(TM) Hydrogel Embolic System | 2025-08-05 |
Recalls
openFDA lists no recalls under a recalling firm named Instylla, Inc..
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.
Device clinical trials
An industry sponsor named Instylla, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT05364502: (HALT) Embrace Hydrogel Embolic System (HES) Study of Embolization in Peripheral Arterial Bleeds (Active not recruiting, started 2022-12-12)
- NCT04523350: Instylla HES Hypervascular Tumor Pivotal Study (Completed, started 2021-01-04)
Frequently asked questions
How many FDA 510(k) clearances are listed under Instylla, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Instylla, Inc.” (first 2019, latest 2026), plus 1 PMA decision, across 4 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 Instylla, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Instylla, Inc. is 38 days. Since 2017: 38 days, versus 154 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Instylla, Inc.?
The most frequent FDA product codes under this applicant name are FMF (Syringe, Piston, 4); KRA (Catheter, Continuous Flush, 4); KRD (Device, Vascular, For Promoting Embolization, 2).
Next steps
- See all 10 Instylla, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FMF, Instylla, 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.