Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
International Medical Industries, Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
199 daysmedian FDA review time
505 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231095 | Tamper Evident Cap | International Medical Industries, Inc. | 2024-09-04 | 505 | 0 |
| K201031 | NRFit® Caps, Male and Female Neuraxial Tip Caps | International Medical Industries, Inc. | 2020-12-16 | 240 | 0 |
| K193192 | Tamper Evident Cap | International Medical Industries, Inc. | 2020-01-31 | 73 | 0 |
| K190305 | Additive Cap | International Medical Industries, Inc. | 2019-04-30 | 77 | 0 |
| K182545 | Tamper Evident Cap with Male Luer Lock | International Medical Industries, Inc. | 2019-01-11 | 116 | 0 |
| K173577 | Guarded Luer Connector | International Medical Industries, Inc. | 2018-06-07 | 199 | 1 |
| K170672 | Tamper Evident Cap For use with ENFit Syringes | International Medical Industries, Inc. | 2017-10-06 | 214 | 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