Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Arbo Medical, Inc. · Predicate Candidate Screening
15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
251 daysmedian FDA review time
443 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K940323 | ARBO DIAGNOSTIC ECG PATIENT CABLES & LEADWIRES ARBO SHIELDED | Arbo Medical, Inc. | 1995-04-12 | 443 | 0 |
| K935437 | ARBO H85V/H87V/H27V DISPOS MONIT ELECTRODES | Arbo Medical, Inc. | 1995-04-06 | 512 | 0 |
| K942905 | DISPOSABLE TEMPERATURE PROBE COVER | Arbo Medical, Inc. | 1995-02-27 | 251 | 0 |
| K940302 | ARBO MONITRING SAFETY CABLE & LEAD WIRE SYSTEMS/ARBO UNSHEIL | Arbo Medical, Inc. | 1994-11-30 | 310 | 0 |
| K940322 | ARBO VS MONITOR CABLE & LEADWIRE SYSTEM ARBO SHIELDED SAFETY | Arbo Medical, Inc. | 1994-11-28 | 308 | 0 |
| K935246 | ARBO H49P, H59P DISPOSABLE MONITORING ELECTRODES | Arbo Medical, Inc. | 1994-11-16 | 380 | 0 |
| K935429 | ARBO H90, H91, H135 DISPOSABLE MONITORING ELECTRODES | Arbo Medical, Inc. | 1994-11-01 | 356 | 0 |
| K935281 | ARBO H87P, H85P, H27P DISPOSABLE MONITORING ELECTRODES | Arbo Medical, Inc. | 1994-09-06 | 307 | 0 |
| K905545 | ULTRASOUND TRANSMISSION GEL | Arbo Medical, Inc. | 1991-03-29 | 108 | 0 |
| K902788 | CLEM TM | Arbo Medical, Inc. | 1990-09-12 | 78 | 0 |
| K901816 | PRESSURE TUBING AND ACCESSORIES | Arbo Medical, Inc. | 1990-07-12 | 80 | 0 |
| K894562 | ARBO H79P DISPOSABLE MONITORING ELECTRODES | Arbo Medical, Inc. | 1989-09-05 | 46 | 0 |
| K894648 | ARBO TAB DISPOSABLE DIAGNOSTIC RESTING EKG ELECTRO | Arbo Medical, Inc. | 1989-09-05 | 43 | 0 |
| K892520 | BREATHING CIRCUIT BACTERIAL FILTERS | Arbo Medical, Inc. | 1989-08-02 | 113 | 0 |
| K884775 | ARBO PINK H82P | Arbo Medical, Inc. | 1989-02-06 | 82 | 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