United Medical Systems, Inc.: FDA clearances and approvals
United Medical Systems, Inc. has 5 FDA 510(k) clearances (first 1986, latest 2008), across 4 product codes in 4 review panels. Median 510(k) review time: 145 days.
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 |
|---|---|---|---|
| LNS | Lithotriptor, Extracorporeal Shock-Wave, Urological | 2 | 2 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 1 |
| HFW | Clamp, Umbilical | 1 | 1 |
| POV | Semen Analysis Device | 1 | 1 |
Review panels
Most recent United Medical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K072538 | PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPTER | LNS | 2008-01-30 | 145 |
| K032958 | PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000 | LNS | 2004-02-17 | 148 |
| K894949 | SQA | POV | 1989-12-29 | 148 |
| K893003 | TOCOLYTIC SITE CARE SUP KIT #1001/100A/CARRY CASE | FOZ | 1989-07-14 | 81 |
| K863645 | SCHULMAN DOUBLE UMBILICAL CORD CLAMP NO. 1000 | HFW | 1986-09-25 | 7 |
Recalls
openFDA lists no recalls under a recalling firm named United Medical Systems, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does United Medical Systems, Inc. have?
United Medical Systems, Inc. has 5 FDA 510(k) clearances (first 1986, latest 2008), across 4 product codes in 4 review panels.
How long does FDA take to clear United Medical Systems, Inc.'s 510(k)s?
The median time from FDA receipt to decision across United Medical Systems, Inc.'s cleared 510(k)s is 145 days.
What devices does United Medical Systems, Inc. make?
Its most frequent FDA product codes are LNS (Lithotriptor, Extracorporeal Shock-Wave, Urological, 2); FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 1); HFW (Clamp, Umbilical, 1).
Has United Medical Systems, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching United Medical Systems, Inc. Related entities may recall under other names.
Next steps
- See all 5 United Medical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LNS, United Medical Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.