Telos Medical Corp.: FDA clearances and approvals
Telos Medical Corp. has 7 FDA 510(k) clearances (first 1988, latest 1992), across 4 product codes in 2 review panels. Median 510(k) review time: 90 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 |
|---|---|---|---|
| DQO | Catheter, Intravascular, Diagnostic | 2 | 2 |
| HFN | Transducer, Pressure, Intrauterine | 2 | 2 |
| KXO | Monitor, Pressure, Intrauterine | 2 | 2 |
| HGS | Catheter, Intrauterine And Introducer | 1 | 1 |
Review panels
Most recent Telos Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K920375 | DISPOSABLE INTRAUTERINE PRESSURE TRANSDUCER | HFN | 1992-10-27 | 272 |
| K920044 | DUAL LUMEN TRANSCERIVICAL INTRAUTERINE KIT | KXO | 1992-04-03 | 88 |
| K914387 | TRANSCERVICAL INTRAUTERINE KIT | HGS | 1991-12-30 | 90 |
| K905018 | LAB-SITE SAFETY NEEDLE | DQO | 1991-01-16 | 70 |
| K905017 | LAB-SITE | DQO | 1991-01-15 | 69 |
| K882224 | ULTRANS DISPOSABLE INTRAUTERINE | HFN | 1989-10-12 | 504 |
| K883832 | CATHETER, INTRAUTERINE AND INTRODUCER | KXO | 1988-12-13 | 95 |
Recalls
openFDA lists no recalls under a recalling firm named Telos Medical Corp..
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 Telos Medical Corp. have?
Telos Medical Corp. has 7 FDA 510(k) clearances (first 1988, latest 1992), across 4 product codes in 2 review panels.
How long does FDA take to clear Telos Medical Corp.'s 510(k)s?
The median time from FDA receipt to decision across Telos Medical Corp.'s cleared 510(k)s is 90 days.
What devices does Telos Medical Corp. make?
Its most frequent FDA product codes are DQO (Catheter, Intravascular, Diagnostic, 2); HFN (Transducer, Pressure, Intrauterine, 2); KXO (Monitor, Pressure, Intrauterine, 2).
Has Telos Medical Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Telos Medical Corp. Related entities may recall under other names.
Next steps
- See all 7 Telos Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code DQO, Telos Medical Corp.'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.