Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Carmel Pharma Ab. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
29 daysmedian FDA review time
99 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K110023 | INFUSION ADAPTER C100 | Carmel Pharma Ab. | 2011-04-12 | 99 | 0 |
| K092782 | INJECTOR LUER, MODEL N34, INJECTOR LUER LOCK, MODEL N35, INJ | Carmel Pharma Ab. | 2009-12-07 | 88 | 0 |
| K090634 | PHASEAL PROTECTOR P14, P21, P28 AND P50 | Carmel Pharma Ab. | 2009-03-23 | 14 | 0 |
| K060866 | PHASEAL - CLOSED SYSTEM FOR THE PREPARATION AND ADMINISTRATI | Carmel Pharma Ab. | 2006-04-28 | 29 | 0 |
| K023747 | PHASEAL | Carmel Pharma Ab. | 2002-11-15 | 7 | 0 |
| K001368 | PROTECTOR 21, PROTECTOR 50, PROTECTOR 14, INJECTOR LUER LOCK | Carmel Pharma Ab. | 2000-05-12 | 11 | 4 |
| K980381 | PHASEAL, CLOSED SYSTEM FORHANDLING OF PARENTERAL DRUGS, ADDI | Carmel Pharma Ab. | 1998-03-03 | 29 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda