Li Medical Technologies, Inc.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Li Medical Technologies, Inc.” (first 1993, latest 2000), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 78 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 |
|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 7 | 7 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 4 | 4 |
| GCJ | Laparoscope, General & Plastic Surgery | 2 | 2 |
| HWC | Screw, Fixation, Bone | 2 | 2 |
| HRX | Arthroscope | 1 | 1 |
| JDR | Staple, Fixation, Bone | 1 | 1 |
Review panels
Most recent Li Medical Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K002413 | ULTRASORB SUTURE ANCHOR | MAI | 2000-09-19 | 43 |
| K993373 | ROTORBLADE SUTURE ANCHOR | MAI | 1999-10-27 | 20 |
| K992938 | ROTORBLADE SUTURE ANCHOR | MAI | 1999-09-23 | 23 |
| K983435 | ROTORBLADE | MAI | 1999-04-29 | 212 |
| K981764 | LM ANCHOR | MBI | 1998-07-13 | 55 |
| K981755 | LM ANCHOR | MBI | 1998-07-13 | 56 |
| K963288 | LM BONE ANCHOR | MBI | 1996-11-13 | 84 |
| K963812 | LM BONE ANCHOR (ORTHOPEDICS) | MBI | 1996-11-12 | 64 |
| K960825 | LM ANCHOR OR OTHER PROPRIETARY NAME | MBI | 1996-04-30 | 61 |
| K960439 | LM BONE ANCHOR | MBI | 1996-04-18 | 78 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Li Medical Technologies, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Li Medical Technologies, Inc.?
FDA lists 17 510(k) clearances under the applicant name “Li Medical Technologies, Inc.” (first 1993, latest 2000), across 6 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 Li Medical Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Li Medical Technologies, Inc. is 78 days.
Which FDA product codes appear under Li Medical Technologies, Inc.?
The most frequent FDA product codes under this applicant name are MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 7); MAI (Fastener, Fixation, Biodegradable, Soft Tissue, 4); GCJ (Laparoscope, General & Plastic Surgery, 2).
Next steps
- See all 17 Li Medical Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MBI, Li Medical Technologies, 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.