Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Can-Am Surgical Corp. — Predicate Candidate Screening

6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

86 daysmedian FDA review time
86 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K870192DISPOSABLE SYRINGE TUBERCULIN W/NEEDLECan-Am Surgical Corp.1987-04-16860
K870191DISPOSABLE SYRINGE WITH NEEDLECan-Am Surgical Corp.1987-04-16860
K870190DISPOSABLE SYRINGE W/O NEEDLECan-Am Surgical Corp.1987-04-16860
K870193A+MED DISPOSABLE NEEDLECan-Am Surgical Corp.1987-02-27380
K870018E-Z JECT INSULIN SYRINGECan-Am Surgical Corp.1987-02-04330
K870017AMG + MED LANCETCan-Am Surgical Corp.1987-01-21190

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