Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
American Viggo · Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
63 daysmedian FDA review time
76 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K771339 | MALE LUER LOCK PLUG | American Viggo | 1977-08-02 | 14 | 0 |
| K770528 | NEEDLE, MEMBRANE | American Viggo | 1977-04-29 | 42 | 0 |
| K770174 | LUER-LOCK EXTENSION SET | American Viggo | 1977-03-30 | 63 | 0 |
| K770181 | I.V. CATHETER PLACEMENT UNIT | American Viggo | 1977-03-30 | 62 | 0 |
| K770154 | 3-WAY STOPCOCK WITH LUER-LOCK FITTING | American Viggo | 1977-02-28 | 35 | 0 |
| K770096 | EPIDURAL BLOCK PROCEDURE PACK | American Viggo | 1977-02-25 | 39 | 0 |
| K760667 | 4-WAY STOPCOCK W/10 CM EXTEN. TUBING | American Viggo | 1976-12-02 | 76 | 0 |
| K760678 | 4-WAY STOPCOCK W/100 CM TUBING, LUER-LK | American Viggo | 1976-12-02 | 73 | 0 |
| K760679 | 4-WAY STOPCOCK W/7CM TUBING, | American Viggo | 1976-12-02 | 73 | 0 |
| K760666 | 4-WAY STOPCOCK W/LUER-LOCK FITTING | American Viggo | 1976-12-02 | 76 | 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