Lhasa Medical, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Lhasa Medical, Inc.” (first 1996, latest 2003), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 83 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQX | Needle, Acupuncture, Single Use | 9 | 9 |
| ILY | Lamp, Infrared, Therapeutic Heating | 2 | 2 |
Review panels
Most recent Lhasa Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K031250 | DBC PRESS ACUPUNCTURE NEEDLES | MQX | 2003-07-15 | 87 |
| K031060 | NANO TECH AND SUPER NANO ACUPUNCTURE NEEDLES | MQX | 2003-07-11 | 99 |
| K023787 | TAI-CHI AND MASTER ACUPUNCTURE NEEDLES | MQX | 2003-02-14 | 93 |
| K013197 | WS-501 HEAT LAMP | ILY | 2002-08-29 | 338 |
| K003538 | TDP CQ-27 HEAT LAMP | ILY | 2001-06-04 | 200 |
| K003760 | TAI-CHI ACUPUNCTURE NEEDLES | MQX | 2001-02-06 | 62 |
| K964529 | CW ACUPUNCTURE NEEDLES | MQX | 1997-01-30 | 79 |
| K964411 | TAKI ACUPUNCTURE NEEDLES | MQX | 1996-12-31 | 83 |
| K963299 | HWA-TO ACUPUNCTURE NEEDLES | MQX | 1996-09-30 | 40 |
| K963300 | DBC ACUPUNTURE NEEDLES(SEVERAL TYPES ARE DESCRIBED ON THE FOLLOWING PAGES) | MQX | 1996-09-23 | 33 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Lhasa Medical, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Lhasa Oms, Inc. (8 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Lhasa Medical, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Lhasa Medical, Inc.” (first 1996, latest 2003), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Lhasa Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lhasa Medical, Inc. is 83 days.
Which FDA product codes appear under Lhasa Medical, Inc.?
The most frequent FDA product codes under this applicant name are MQX (Needle, Acupuncture, Single Use, 9); ILY (Lamp, Infrared, Therapeutic Heating, 2).
Next steps
- See all 11 Lhasa Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MQX, Lhasa Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.