Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Inneuroco, Inc. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
137 daysmedian FDA review time
275 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232260 | Thinline Sheath Introducer | Inneuroco, Inc. | 2023-09-27 | 58 | 0 |
| K220331 | 091 Balloon Guide Catheter | Inneuroco, Inc. | 2022-07-29 | 175 | 0 |
| K190338 | 046 Zenith Flex | Inneuroco, Inc. | 2019-08-02 | 169 | 0 |
| K181354 | 074 Zenith Flex System | Inneuroco, Inc. | 2018-10-25 | 156 | 0 |
| K172167 | Zenith Flex System | Inneuroco, Inc. | 2018-04-19 | 275 | 0 |
| K173709 | Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Suppor | Inneuroco, Inc. | 2018-01-26 | 53 | 0 |
| K172468 | 091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long She | Inneuroco, Inc. | 2017-12-06 | 113 | 1 |
| K171672 | 065 Zenith, 074 Zenith | Inneuroco, Inc. | 2017-10-19 | 135 | 0 |
| K161262 | Super Distal Access (SDA) | Inneuroco, Inc. | 2016-09-19 | 137 | 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