Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Thermoscan, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
179 daysmedian FDA review time
525 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K964605 | BRAUN THERMOSCAN PRO-2000 INSTANT THERMOMETER (PRO-2000) | Thermoscan, Inc. | 1997-05-16 | 179 | 0 |
| K954523 | THERMOSCAN INSTANT THERMOMETER MODEL IR-6000 | Thermoscan, Inc. | 1996-12-10 | 438 | 0 |
| K930680 | THERMOSCAN INSTANT THERMOMETER IR-5000 | Thermoscan, Inc. | 1994-07-20 | 525 | 0 |
| K902912 | THERMOSCAN-INSTANT THERMOMETER MODEL IR-4000 | Thermoscan, Inc. | 1990-07-24 | 21 | 0 |
| K896952 | THERMOSCAN-INSTANT THERMOMETER MODEL IR-2000 | Thermoscan, Inc. | 1990-03-07 | 82 | 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