Talley Group, Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Talley Group, Ltd.” (first 1991, latest 2016), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 140 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 | 2 | 362 |
| 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 |
|---|---|---|---|
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | 2 | 2 |
| FNM | Mattress, Air Flotation, Alternating Pressure | 1 | 1 |
| IKE | Transducer, Miniature Pressure | 1 | 1 |
| IRP | Massager, Powered Inflatable Tube | 1 | 1 |
| JFC | System, Pressure Measurement, Intermittent | 1 | 1 |
Review panels
Most recent Talley Group, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K151263 | Venturi Gauze Wound Care Sets with Portal Drain | OMP | 2016-02-19 | 282 |
| K143004 | VENTURI MiNO TG600/14 | OMP | 2016-01-05 | 442 |
| K914775 | TALLEY MICRO SYSTEM/TALLEY RIPPLEBED | FNM | 1992-04-10 | 170 |
| K914774 | MULTIPULSE SEQUENTIAL COMPRESSION UNIT | IRP | 1992-02-11 | 111 |
| K914780 | TALLEY SD.500 SKIN PRESSURE EVALUATOR | IKE | 1991-12-19 | 57 |
| K914776 | OXFORD PRESSURE MONITOR/TALLEY PRESSURE MONITOR | JFC | 1991-12-19 | 57 |
Recalls
openFDA lists no recalls under a recalling firm named Talley Group, Ltd..
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.
- Talley Medical (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Talley Group, Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Talley Group, Ltd.” (first 1991, latest 2016), across 5 product codes in 3 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 Talley Group, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Talley Group, Ltd. is 140 days.
Which FDA product codes appear under Talley Group, Ltd.?
The most frequent FDA product codes under this applicant name are OMP (Negative Pressure Wound Therapy Powered Suction Pump, 2); FNM (Mattress, Air Flotation, Alternating Pressure, 1); IKE (Transducer, Miniature Pressure, 1).
Next steps
- See all 6 Talley Group, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code OMP, Talley Group, Ltd.'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.