Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Instylla, Inc. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
46 daysmedian FDA review time
262 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261610 | Verge™ Microcatheter | Instylla, Inc. | 2026-06-11 | 28 | 0 |
| K253769 | Instylla Delivery Kit | Instylla, Inc. | 2025-12-22 | 27 | 0 |
| K253677 | Tembo Embolic System | Instylla, Inc. | 2025-12-15 | 24 | 0 |
| K240873 | TEMBO Embolic System | Instylla, Inc. | 2024-12-16 | 262 | 0 |
| K213632 | Instylla Delivery Kit | Instylla, Inc. | 2022-02-10 | 85 | 0 |
| K210808 | Instylla Microcatheter 1.2 | Instylla, Inc. | 2021-04-15 | 29 | 0 |
| K202544 | Instylla Delivery Kit | Instylla, Inc. | 2021-01-07 | 127 | 0 |
| K200744 | Instylla Microcatheter | Instylla, Inc. | 2020-04-21 | 29 | 0 |
| K191659 | Instylla Delivery Kit | Instylla, Inc. | 2019-10-10 | 111 | 0 |
| K191731 | Instylla Microcatheter | Instylla, Inc. | 2019-08-13 | 46 | 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