Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Andromed, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
91 daysmedian FDA review time
228 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K051779 | ANDROFLOW - RESPIRATORY RATE MONITOR | Andromed, Inc. | 2005-09-30 | 91 | 0 |
| K022298 | I-STETHOS LINK | Andromed, Inc. | 2002-10-01 | 77 | 0 |
| K021389 | BIOLOGICAL SOUND MONITOR (BSM) SENSOR | Andromed, Inc. | 2002-10-01 | 152 | 0 |
| K010729 | AGILENT ELECTRONIC STETHOSCOPE, MODELS M4532A AND M4533A | Andromed, Inc. | 2001-10-26 | 228 | 0 |
| K001306 | STETHOS, MODEL STXXYYZZ OR 001 XXX, STETHOS LINK, MODEL SLXX | Andromed, Inc. | 2000-07-20 | 86 | 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