Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Scanlan Intl., Inc. — Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
54 daysmedian FDA review time
113 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K960372 | SCANLAN HEIFETZ ANEURYSM ELGILOY CLIP SYSTEM | Scanlan Intl., Inc. | 1996-04-26 | 91 | 0 |
| K945474 | SCANLAN(R) THORACOSCOPIC SCISSORS, CLAMP, FORCEPS, NEEDLE HO | Scanlan Intl., Inc. | 1994-12-05 | 27 | 0 |
| K911184 | SCANLAN/TAHERI VALVULOTOME | Scanlan Intl., Inc. | 1992-02-18 | 337 | 0 |
| K864920 | SCANLAN (TM) INSTRUMENT TRAY | Scanlan Intl., Inc. | 1987-01-12 | 27 | 0 |
| K864919 | SCANLAN (TM) VEIN/GRAFT HOLDER | Scanlan Intl., Inc. | 1987-01-12 | 27 | 0 |
| K851825 | SCANLAN TUNNELER, SHEATH & TIP | Scanlan Intl., Inc. | 1985-07-12 | 77 | 0 |
| K841521 | SCANLAN ENDARSECTOR | Scanlan Intl., Inc. | 1984-08-03 | 113 | 0 |
| K841513 | SCANLAN ATRAUM INSTRUMENT JAW COVER | Scanlan Intl., Inc. | 1984-07-06 | 85 | 0 |
| K841085 | SCANLAN COLORMARK SKIN MARKER | Scanlan Intl., Inc. | 1984-06-11 | 90 | 0 |
| K841515 | SCANLAN VASCU-STATT II | Scanlan Intl., Inc. | 1984-06-05 | 54 | 0 |
| K841514 | SCANLAN VASCU-STATT II APPROXIMATOR | Scanlan Intl., Inc. | 1984-06-05 | 54 | 0 |
| K841086 | SURGICAL INSTRUMENT DEMAGNETIZER | Scanlan Intl., Inc. | 1984-04-24 | 42 | 0 |
| K823764 | SCANLAN SINGLE-USE AORTA PUNCH | Scanlan Intl., Inc. | 1983-03-24 | 100 | 0 |
| K823694 | VASCU-STATT APPROXIMATOR | Scanlan Intl., Inc. | 1983-01-07 | 30 | 0 |
| K821887 | SCANLAN SUTURE-STATT | Scanlan Intl., Inc. | 1982-07-28 | 33 | 0 |
| K810480 | SCANLAN SUTURE BOOTS | Scanlan Intl., Inc. | 1981-03-13 | 18 | 0 |
| K802829 | SCANLAN VASCU-STATT | Scanlan Intl., Inc. | 1981-01-15 | 66 | 0 |
| K801976 | SCANLAN STERNUM NEEDLE-SUTURE | Scanlan Intl., Inc. | 1980-09-26 | 38 | 0 |
| K780255 | NEEDLE DRIVER | Scanlan Intl., Inc. | 1978-04-18 | 61 | 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