Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sscor — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
17 daysmedian FDA review time
81 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K041154 | S-SCORT...JR QUICKDRAW, MODEL 2400 | Sscor | 2004-05-18 | 15 | 0 |
| K964997 | S-SCORT (2500) | Sscor | 1997-03-05 | 79 | 0 |
| K952632 | S-SCORT | Sscor | 1995-06-16 | 8 | 0 |
| K950464 | SSCOR/BOARD ..3 MODEL 23000 PRE-ASSEMBLED SUCTION SYSTEM FOR | Sscor | 1995-04-25 | 81 | 0 |
| K945929 | S-SCORT(R)DUET MODEL 2014 PORTABLE SUCTION PUMP | Sscor | 1994-12-22 | 17 | 1 |
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