Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Axelgaard Mfg. Co., Ltd. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
87 daysmedian FDA review time
192 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K132422 | PALS PLATINUM NEUROSTIMULATION ELECTRODES | Axelgaard Mfg. Co., Ltd. | 2014-02-13 | 192 | 0 |
| K130987 | VALUTRODE NEUROSTIMLATION ELECTRODES | Axelgaard Mfg. Co., Ltd. | 2013-07-17 | 99 | 0 |
| K080580 | COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELE | Axelgaard Mfg. Co., Ltd. | 2008-06-18 | 107 | 0 |
| K013532 | ULTRASTIM KIT | Axelgaard Mfg. Co., Ltd. | 2002-08-22 | 309 | 0 |
| K000947 | ULTRASTIM ELECTRODE, MODEL US4040 | Axelgaard Mfg. Co., Ltd. | 2000-06-16 | 85 | 0 |
| K000206 | PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200 | Axelgaard Mfg. Co., Ltd. | 2000-04-13 | 83 | 0 |
| K983741 | EVERLAST NEUROSTIMULATION ELECTRODES 2X 2,MODEL # EL2020 | Axelgaard Mfg. Co., Ltd. | 1998-12-18 | 57 | 0 |
| K970426 | VALUETRODE | Axelgaard Mfg. Co., Ltd. | 1997-05-09 | 94 | 0 |
| K874469 | TRANSCUTANEOUS ELECTRIC NERVE STIMULATION (TENS) | Axelgaard Mfg. Co., Ltd. | 1988-01-28 | 87 | 0 |
| K872976 | TENS PALS PLUS | Axelgaard Mfg. Co., Ltd. | 1987-09-22 | 54 | 0 |
| K852267 | ELECTRICAL NERVE STIMULATION(TENS) ELECTRODES | Axelgaard Mfg. Co., Ltd. | 1985-06-18 | 21 | 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