Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
North American Technical Services Corp. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
198 daysmedian FDA review time
515 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K974321 | HYDROTONE | North American Technical Services Corp. | 1998-06-22 | 217 | 0 |
| K970590 | N/A | North American Technical Services Corp. | 1997-06-13 | 115 | 0 |
| K970592 | N/A | North American Technical Services Corp. | 1997-06-13 | 115 | 0 |
| K961582 | EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100 | North American Technical Services Corp. | 1996-11-08 | 198 | 0 |
| K953440 | ELLMAN LAPTRODE | North American Technical Services Corp. | 1995-08-29 | 48 | 0 |
| K944558 | ELLMAN VAPOR-VAC II | North American Technical Services Corp. | 1995-04-28 | 224 | 0 |
| K944730 | MASSAGER | North American Technical Services Corp. | 1995-02-14 | 141 | 0 |
| K932204 | E-Z THERM 3 SECOND THERMOMETER | North American Technical Services Corp. | 1994-10-03 | 515 | 0 |
| K914364 | ASTOTHERM IFT 250, IFT 260, ASTOTUBE VARIOUS NO. | North American Technical Services Corp. | 1992-09-10 | 345 | 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