Carmel Pharma Ab.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Carmel Pharma Ab.” (first 1998, latest 2011), across 1 product code in 1 review panel. Median 510(k) review time under this name: 29 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 |
|---|---|---|---|
| LHI | Set, I.V. Fluid Transfer | 7 | 7 |
Review panels
- General Hospital (7)
Most recent Carmel Pharma Ab. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K110023 | INFUSION ADAPTER C100 | LHI | 2011-04-12 | 99 |
| K092782 | INJECTOR LUER, MODEL N34, INJECTOR LUER LOCK, MODEL N35, INJECTOR LUER LOCK, N35C, CONNECTOR LUER LOCK, MODEL C35, | LHI | 2009-12-07 | 88 |
| K090634 | PHASEAL PROTECTOR P14, P21, P28 AND P50 | LHI | 2009-03-23 | 14 |
| K060866 | PHASEAL - CLOSED SYSTEM FOR THE PREPARATION AND ADMINISTRATION OF PARENTERAL DRUGS | LHI | 2006-04-28 | 29 |
| K023747 | PHASEAL | LHI | 2002-11-15 | 7 |
| K001368 | PROTECTOR 21, PROTECTOR 50, PROTECTOR 14, INJECTOR LUER LOCK, INFUSION ADAPTER | LHI | 2000-05-12 | 11 |
| K980381 | PHASEAL, CLOSED SYSTEM FORHANDLING OF PARENTERAL DRUGS, ADDITIONAL ADMINISTRATION DEVICES. C80 INFUSION ADAPTER, A10 PRO | LHI | 1998-03-03 | 29 |
Recalls
openFDA lists no recalls under a recalling firm named Carmel Pharma Ab..
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.
- Carmel Medical Devices (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Carmel Pharma Ab.?
FDA lists 7 510(k) clearances under the applicant name “Carmel Pharma Ab.” (first 1998, latest 2011), across 1 product code 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 Carmel Pharma Ab.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Carmel Pharma Ab. is 29 days.
Which FDA product codes appear under Carmel Pharma Ab.?
The most frequent FDA product codes under this applicant name are LHI (Set, I.V. Fluid Transfer, 7).
Next steps
- See all 7 Carmel Pharma Ab. clearances with predicates and recalls
- Run predicate analysis for product code LHI, Carmel Pharma Ab.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.