Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
American Institute of Koryo Hand Therapy · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
59 daysmedian FDA review time
62 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K980471 | KHT GUAM NEEDLE, ACUPUNCTURE NEEDLE | American Institute of Koryo Hand Therapy | 1998-04-09 | 62 | 0 |
| K980472 | KHT SOFT NEEDLE, ACUPUNCTURE NEEDLE | American Institute of Koryo Hand Therapy | 1998-04-09 | 62 | 0 |
| K980470 | KHT SOFT SOOJI NEEDLE, HAND ACUPUNCTURE NEEDLE | American Institute of Koryo Hand Therapy | 1998-04-06 | 59 | 0 |
| K980469 | KHT SOOJI NEEDLE, HAND ACUPUNCTURE NEEDLE | American Institute of Koryo Hand Therapy | 1998-04-03 | 56 | 0 |
| K974527 | KHT SEOAM NEEDLE, HAND ACUPUNCTURE NEEDLE | American Institute of Koryo Hand Therapy | 1998-01-13 | 42 | 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