Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medical Electronic Devices, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
35 daysmedian FDA review time
224 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K052563 | INOGEN SATELLITE CONSERVER, MODEL SC-100 | Medical Electronic Devices, Inc. | 2005-10-24 | 35 | 0 |
| K033197 | INOGEN SATELLITE CONSERVER | Medical Electronic Devices, Inc. | 2004-05-13 | 224 | 0 |
| K023420 | PULSED OXYGEN CONSERVING DEVICE - EVERY BREATH, POCDEB, REAC | Medical Electronic Devices, Inc. | 2002-10-25 | 14 | 0 |
| K983601 | DEMAND OXYGEN CONSERVING DEVICE, DOCD, THE DOC | Medical Electronic Devices, Inc. | 1998-12-15 | 62 | 0 |
| K983459 | PULSED OXYGEN CONSERVING DEVICE, POCD | Medical Electronic Devices, Inc. | 1998-12-08 | 69 | 0 |
| K770115 | ARTERIAL DIAGNOSTIC UNIT (ADU) | Medical Electronic Devices, Inc. | 1977-02-01 | 13 | 0 |
| K761092 | INGUINAL COMPRESSIVE DEVICE (ICD) | Medical Electronic Devices, Inc. | 1976-12-16 | 24 | 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