Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Transtracheal Systems — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
121 daysmedian FDA review time
325 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K982943 | TRANSTRACHEAL DEMAND OXYGEN CONTROLLER MODEL DOC-3000 | Transtracheal Systems | 1999-07-12 | 325 | 0 |
| K981078 | TRANSTRACHEAL AUGMENTED VENTILATION OXYGEN CONCENTRATOR MODE | Transtracheal Systems | 1998-07-23 | 121 | 0 |
| K981080 | SCOOP 1 | Transtracheal Systems | 1998-06-17 | 85 | 0 |
| K962944 | TRANSTRACHEAL DEMAND OXYGEN CONTROLLER (DOC-2000) | Transtracheal Systems | 1996-10-23 | 89 | 0 |
| K904749 | TRANSKINETICS RADO FREQ MULTI-LEAD TELE SYST 7200 | Transtracheal Systems | 1991-03-01 | 133 | 0 |
| K904748 | TRANSKINETICS INFRARED MULTI-LEAD TELE SYST 7100 | Transtracheal Systems | 1991-03-01 | 133 | 0 |
| K902281 | MODIFIED SCOOP TRANSTRACHEAL CATHETERS | Transtracheal Systems | 1990-08-10 | 80 | 0 |
| K854252 | TRANSTRACHEAL SYSTEM-SCOOP-INSERTION TRAY-CATHETER | Transtracheal Systems | 1986-02-03 | 104 | 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