Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lhasa Medical, Inc. · Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
83 daysmedian FDA review time
200 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K031250 | DBC PRESS ACUPUNCTURE NEEDLES | Lhasa Medical, Inc. | 2003-07-15 | 87 | 0 |
| K031060 | NANO TECH AND SUPER NANO ACUPUNCTURE NEEDLES | Lhasa Medical, Inc. | 2003-07-11 | 99 | 0 |
| K023787 | TAI-CHI AND MASTER ACUPUNCTURE NEEDLES | Lhasa Medical, Inc. | 2003-02-14 | 93 | 0 |
| K013197 | WS-501 HEAT LAMP | Lhasa Medical, Inc. | 2002-08-29 | 338 | 0 |
| K003538 | TDP CQ-27 HEAT LAMP | Lhasa Medical, Inc. | 2001-06-04 | 200 | 0 |
| K003760 | TAI-CHI ACUPUNCTURE NEEDLES | Lhasa Medical, Inc. | 2001-02-06 | 62 | 0 |
| K964529 | CW ACUPUNCTURE NEEDLES | Lhasa Medical, Inc. | 1997-01-30 | 79 | 0 |
| K964411 | TAKI ACUPUNCTURE NEEDLES | Lhasa Medical, Inc. | 1996-12-31 | 83 | 0 |
| K963299 | HWA-TO ACUPUNCTURE NEEDLES | Lhasa Medical, Inc. | 1996-09-30 | 40 | 0 |
| K963300 | DBC ACUPUNTURE NEEDLES(SEVERAL TYPES ARE DESCRIBED ON THE FO | Lhasa Medical, Inc. | 1996-09-23 | 33 | 0 |
| K962916 | HUA-XIA ACUPUNCTURE NEEDLES | Lhasa Medical, Inc. | 1996-08-23 | 28 | 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