Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sendx Medical, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
119 daysmedian FDA review time
172 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K151639 | ABL80 FLEX and ABL80 FLEX CO-OX | Sendx Medical, Inc. | 2015-12-07 | 172 | 0 |
| K151856 | ABL80 FLEX CO-OX with AQURE connectivity | Sendx Medical, Inc. | 2015-08-06 | 29 | 3 |
| K080370 | ABL 80 CO-OX SYSTEM | Sendx Medical, Inc. | 2008-07-31 | 170 | 3 |
| K051804 | ABL80 FLEX ANALYZER | Sendx Medical, Inc. | 2005-11-01 | 119 | 3 |
| K994346 | ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM | Sendx Medical, Inc. | 2000-02-01 | 40 | 1 |
| K973742 | SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM | Sendx Medical, Inc. | 1997-12-03 | 63 | 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