Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Alpha-Omega Services, Inc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
244 daysmedian FDA review time
293 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233628 | AOS Interstitial Templates, Needles, and Accessories | Alpha-Omega Services, Inc. | 2024-07-10 | 240 | 0 |
| K233626 | AOS Marker Seeds (SMG0242-025) | Alpha-Omega Services, Inc. | 2024-07-02 | 232 | 0 |
| K102811 | AOS ORION IR-192 SOURCE CABLE | Alpha-Omega Services, Inc. | 2011-06-02 | 247 | 0 |
| K062824 | AOS UNIVERSAL CONECTING GUIDE TUBE | Alpha-Omega Services, Inc. | 2007-07-03 | 286 | 0 |
| K062823 | AOS INTERSTITIAL TEMPLATES, NEEDLES & ACCESSORIES | Alpha-Omega Services, Inc. | 2007-05-29 | 251 | 0 |
| K062826 | AOS IMPLANT TUBES, IMPLANT NEEDLES & RETAINING BOTTONS | Alpha-Omega Services, Inc. | 2007-05-22 | 244 | 0 |
| K062825 | AOS MARKER SEEDS | Alpha-Omega Services, Inc. | 2007-05-22 | 244 | 0 |
| K991571 | 10 CURIE IRDIUM 192, CSN00100-192 | Alpha-Omega Services, Inc. | 2000-02-22 | 293 | 0 |
| K964910 | AOS UNIVERSAL CONNECTING GUIDE TUBE FOR HIGH DOSE RATE AFTER | Alpha-Omega Services, Inc. | 1997-03-10 | 91 | 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