Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ultramed, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
84 daysmedian FDA review time
154 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K882015 | TRANSCRAN(TM) TRANSCRANIAL PULSED DOPPLER SYSTEM | Ultramed, Inc. | 1988-09-08 | 118 | 0 |
| K873989 | DOPPLEX ULTRASONIC DOPPLER SYSTEM | Ultramed, Inc. | 1988-03-02 | 154 | 0 |
| K861378 | ULTRAMED TF 122 ULTRASON VASCU IMAG & DOPPLER SYST | Ultramed, Inc. | 1986-07-07 | 84 | 0 |
| K862021 | PHACOEMULSIFICATION ULTRASONIC FRAGMENT SYSTEM | Ultramed, Inc. | 1986-06-23 | 26 | 0 |
| K850578 | PHACOEMULSIFICATION TIP | Ultramed, Inc. | 1985-04-03 | 49 | 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