Deltex Medical Limited: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Deltex Medical Limited” (first 2009, latest 2018), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 152 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 | 1 | 91 |
| 2014 | 0 | — |
| 2015 | 2 | 134 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 318 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Deltex Medical Limited took a median 318 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 136 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DPW | Flowmeter, Blood, Cardiovascular | 4 | 4 |
| DPT | Probe, Blood-Flow, Extravascular | 2 | 2 |
Review panels
- Cardiovascular (6)
Most recent Deltex Medical Limited 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K172457 | Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM | DPW | 2018-06-28 | 318 |
| K150347 | Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+ | DPW | 2015-07-24 | 163 |
| K142932 | Deltex Medical KDP72 Doppler Probe | DPT | 2015-01-22 | 105 |
| K132139 | DELTEX MEDICAL CARDIOQ-EDM+ | DPW | 2013-10-10 | 91 |
| K111542 | DELTEX MEDICAL CARDIOQ EDM | DPW | 2011-10-20 | 140 |
| K073593 | I2S DOPPLER PROBE ( 6 HOUR), I2S DOPPLER PROBE (24 HOUR), I2C DOPPLER PROBE (72 HOUR), MODELS 9090-7015, 9090-7016 | DPT | 2009-01-29 | 405 |
Recalls
openFDA lists no recalls under a recalling firm named Deltex Medical Limited.
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.
- Deltex Medical (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Deltex Medical Limited?
FDA lists 6 510(k) clearances under the applicant name “Deltex Medical Limited” (first 2009, latest 2018), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Deltex Medical Limited?
The median time from FDA receipt to decision across 510(k)s cleared under the name Deltex Medical Limited is 152 days.
Which FDA product codes appear under Deltex Medical Limited?
The most frequent FDA product codes under this applicant name are DPW (Flowmeter, Blood, Cardiovascular, 4); DPT (Probe, Blood-Flow, Extravascular, 2).
Next steps
- See all 6 Deltex Medical Limited clearances with predicates and recalls
- Run predicate analysis for product code DPW, Deltex Medical Limited'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.