Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Oriental System Technology, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
85 daysmedian FDA review time
165 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K042202 | TEMPTELLER - HIGH SPEED DIGITAL THERMOMETERS, MODELS DT-302, | Oriental System Technology, Inc. | 2004-09-10 | 28 | 0 |
| K030299 | TEMPTELLER INFARED EAR THERMOMETERS, MODEL CT-31/31DX/32/32D | Oriental System Technology, Inc. | 2003-02-25 | 27 | 0 |
| K010235 | TEMPTELLER INFRARED EAR THERMOMETER, MODEL CT-30/ CT-30DX | Oriental System Technology, Inc. | 2001-07-09 | 165 | 0 |
| K001008 | TEMPTELLER INFRARED EAR THERMOMETER, MODELS TT-901, TT-911 A | Oriental System Technology, Inc. | 2000-04-12 | 14 | 0 |
| K992601 | TEMP TELLER - DIGITAL THERMOMETER, MODELS DT-101, DT-102, DT | Oriental System Technology, Inc. | 1999-10-27 | 85 | 0 |
| K984497 | TEMP TELLER-INFRARED TYMPANIC THERMOMETER, MODELS TT-200, TT | Oriental System Technology, Inc. | 1999-05-26 | 160 | 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