Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
North American Science Assoc., Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
205 daysmedian FDA review time
445 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K141244 | NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (DUAL SPECIES) NAMSA | North American Science Assoc., Inc. | 2014-09-09 | 118 | 0 |
| K132291 | NAMSA CHEMICAL PROCESS | North American Science Assoc., Inc. | 2014-05-20 | 301 | 0 |
| K113221 | NAMSA BIOLOGICAL INDICATOR SPORE STRIPS | North American Science Assoc., Inc. | 2012-04-27 | 178 | 0 |
| K113302 | NAMSA STEAM SELF-CONTAINED BIOLOGICAL INDICATORS | North American Science Assoc., Inc. | 2012-01-20 | 73 | 0 |
| K983451 | CHALLENGE TEST PACK | North American Science Assoc., Inc. | 1999-04-23 | 205 | 0 |
| K962649 | SPORTROL RAPID STERILITY INDICATOR | North American Science Assoc., Inc. | 1997-09-26 | 445 | 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