Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Andronic Devices, Ltd. — Predicate Candidate Screening
16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
138 daysmedian FDA review time
269 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K940812 | INSIGHT ELECTRONIC ALIGNMENT INDICATOR | Andronic Devices, Ltd. | 1994-11-21 | 272 | 0 |
| K934928 | INSITE FILTER & TUBING SET | Andronic Devices, Ltd. | 1994-05-26 | 224 | 0 |
| K934926 | INSITE MODEL 20 & MODEL 15 INSUFFLATORS | Andronic Devices, Ltd. | 1994-05-26 | 224 | 0 |
| K935381 | KAPS POSITIONING ARM | Andronic Devices, Ltd. | 1994-04-15 | 158 | 0 |
| K934124 | AUTOQUOT AUTOMATED ALIQUOTTING SYSTEM | Andronic Devices, Ltd. | 1994-04-13 | 231 | 0 |
| K936308 | ENDEX ENDOSCOPIC POSITIONING SYSTEM | Andronic Devices, Ltd. | 1994-03-31 | 101 | 0 |
| K932253 | ARTHROBOT BI-FOLD DRAPE | Andronic Devices, Ltd. | 1994-02-03 | 269 | 0 |
| K922626 | ADEPT INSTRUMENT POSITIONING ACCESSORY | Andronic Devices, Ltd. | 1992-10-19 | 138 | 0 |
| K922625 | ADEPT ENDOSCOPIC POSITIONER | Andronic Devices, Ltd. | 1992-10-19 | 138 | 0 |
| K911521 | ARTHROBOT(TM) 96 (240 CM) DRAPE WITH 1 STRAP | Andronic Devices, Ltd. | 1991-08-02 | 120 | 0 |
| K911520 | ARTHROBOT(TM) 75 (190 CM) GENERAL PURPOSE DRAPE | Andronic Devices, Ltd. | 1991-08-02 | 120 | 0 |
| K911522 | ARTHROBOT(TM) WRIST HOLDER ACCESSORY | Andronic Devices, Ltd. | 1991-04-29 | 25 | 0 |
| K880227 | ARTHROBOT(TM) LOWER LIMB POSITIONER | Andronic Devices, Ltd. | 1988-02-18 | 29 | 0 |
| K874762 | ARTHROTRACT UPPER LIMB TRACTION ACCESSORY | Andronic Devices, Ltd. | 1987-12-10 | 21 | 0 |
| K873080 | ARTHROBOT 101 UPPER LIMB TRACTION ACCESSORY | Andronic Devices, Ltd. | 1987-11-25 | 112 | 0 |
| K873079 | ARTHROBOT 100 UPPER LIMB POSITIONER | Andronic Devices, Ltd. | 1987-11-25 | 112 | 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