Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mallinckroot, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
85 daysmedian FDA review time
168 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K983830 | COPPERHEAD 5 FR. PTA CATHETER, FINCH 4 FR. PTA CATHETER | Mallinckroot, Inc. | 1999-04-16 | 168 | 0 |
| K894445 | MODIFIED SOFTOUCH INTRODUCER W/HEMO VALVE & SIDE | Mallinckroot, Inc. | 1989-10-02 | 77 | 0 |
| K885348 | A-V(TM) SOFTOUCH UHF CARDIAC PIGTAIL | Mallinckroot, Inc. | 1989-05-15 | 138 | 0 |
| K885216 | ATTACHABLE LANZ (TENTATIVE) | Mallinckroot, Inc. | 1989-03-14 | 85 | 0 |
| K884159 | SOFTOUCH INTRODUCER W/HEMOSTASIS VALVE & SIDEPORT | Mallinckroot, Inc. | 1989-02-22 | 141 | 0 |
| K884481 | CLEAR SHOT ANGIOPLASTY BALLOON INFLATION DEVICE | Mallinckroot, Inc. | 1989-01-10 | 80 | 0 |
| K882130 | FOLEY-TEMP(TM) | Mallinckroot, Inc. | 1988-08-09 | 81 | 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