Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Skylark Device Co., Ltd. — Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
223 daysmedian FDA review time
497 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K990233 | ST-302 INFRAREX | Skylark Device Co., Ltd. | 1999-10-27 | 275 | 0 |
| K984506 | SD-100 SKYEAR THERMOMETER | Skylark Device Co., Ltd. | 1999-07-29 | 223 | 0 |
| K981449 | SD-956 ULTRASOUND THERAPY | Skylark Device Co., Ltd. | 1998-12-11 | 233 | 0 |
| K983964 | BATCH #6060 CONDUCTIVE GEL | Skylark Device Co., Ltd. | 1998-12-09 | 33 | 0 |
| K964437 | GB-1002 TENS WITH MASSAGE | Skylark Device Co., Ltd. | 1998-08-14 | 647 | 0 |
| K974585 | IF-727 INTERFERENTIAL STIMULATOR | Skylark Device Co., Ltd. | 1998-03-06 | 88 | 0 |
| K964434 | SD-970EMS ELECTRICAL MUSCULAR STIMULATOR | Skylark Device Co., Ltd. | 1997-10-09 | 338 | 0 |
| K963729 | SD-610M(ALSO KNOWN AS STANDARD TENS, SD-609M,SD-611M, GLC-I | Skylark Device Co., Ltd. | 1997-02-13 | 150 | 0 |
| K946337 | IT-727 (ALSO KNOWN AS IT-610, IT-600 AND DYNAPHOR II | Skylark Device Co., Ltd. | 1995-12-20 | 356 | 0 |
| K946299 | PGS123 AND HVS-123 | Skylark Device Co., Ltd. | 1995-06-26 | 181 | 0 |
| K934051 | BIO SDP (AKA SATURN SD, GLC-III SD & STAT-SD) | Skylark Device Co., Ltd. | 1994-07-11 | 326 | 0 |
| K930535 | IF400 | Skylark Device Co., Ltd. | 1994-06-14 | 497 | 0 |
| K931079 | STAT-TENS | Skylark Device Co., Ltd. | 1994-06-09 | 463 | 0 |
| K925729 | SD-602 SD MODE 11, SD-603 SD MOD 111 | Skylark Device Co., Ltd. | 1993-01-22 | 70 | 0 |
| K923934 | TX-3 SD | Skylark Device Co., Ltd. | 1992-10-23 | 79 | 0 |
| K923935 | SD-605 SD II PROGRAM | Skylark Device Co., Ltd. | 1992-10-15 | 71 | 0 |
| K923298 | MICRO 100,200,300, & 400 TENS | Skylark Device Co., Ltd. | 1992-10-13 | 99 | 0 |
| K912643 | ELECTRODE | Skylark Device Co., Ltd. | 1992-02-14 | 245 | 0 |
| K912642 | EMS300, EMS400, EMS8000 | Skylark Device Co., Ltd. | 1991-12-09 | 178 | 0 |
| K912178 | BIO TENS 601, 606 AND 608 (3000) | Skylark Device Co., Ltd. | 1991-10-25 | 162 | 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