Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pathway Medical Technologies, Inc. — Predicate Candidate Screening
16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
30 daysmedian FDA review time
66 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K120242 | JETSTREAM NAVITUS L SYSTEM | Pathway Medical Technologies, Inc. | 2012-02-24 | 28 | 0 |
| K111229 | JETSTREAM G3 (R) SF 1.6 SYSTEM | Pathway Medical Technologies, Inc. | 2011-06-01 | 30 | 0 |
| K110626 | JETSTREAM NAVITUS SYSTEM; JETSTREAM G3 SF SYSTEM; JETSTREAM | Pathway Medical Technologies, Inc. | 2011-04-20 | 47 | 0 |
| K101334 | JETSTREAM G3 SE SYSTEM, JETSTREAM G3 SF SYSTEM MODEL PV31230 | Pathway Medical Technologies, Inc. | 2010-06-11 | 30 | 0 |
| K101221 | JETSTREAM G3 SYSTEM, MODEL PV31300, PV CONSOLE, MODEL PVCN10 | Pathway Medical Technologies, Inc. | 2010-06-02 | 30 | 0 |
| K100462 | JETSTREAM G3 L SYSTEM, PV CONSOLE, MODELS PV31400, PV31300, | Pathway Medical Technologies, Inc. | 2010-05-19 | 90 | 0 |
| K093918 | JETSTREAM G3 L SYSTEM MODEL PV31400 (JETSTREAM G3 L CATHETER | Pathway Medical Technologies, Inc. | 2010-01-21 | 30 | 0 |
| K093456 | JETSTREAM G3 SYSTEM | Pathway Medical Technologies, Inc. | 2009-12-01 | 26 | 0 |
| K092332 | JETSTREAM G3 SYSTEM, MODEL PV31300 ( JETSTREAM G3 CATHETER A | Pathway Medical Technologies, Inc. | 2009-09-03 | 30 | 0 |
| K091509 | JETSTREAM G2 NXT SYSTEM, MODEL PV20300 | Pathway Medical Technologies, Inc. | 2009-06-19 | 28 | 0 |
| K090325 | JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER A | Pathway Medical Technologies, Inc. | 2009-03-11 | 30 | 0 |
| K083489 | JETSTREAM PATHWAY PC ATHERECTOMY SYSTEM, MODEL OV10300 | Pathway Medical Technologies, Inc. | 2009-01-23 | 59 | 0 |
| K083837 | JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER A | Pathway Medical Technologies, Inc. | 2009-01-13 | 21 | 0 |
| K082664 | JETSTREAM PATHWAY PV ATHERECTOMY SYSTEM, MODEL PV10300, PVCN | Pathway Medical Technologies, Inc. | 2008-10-06 | 24 | 0 |
| K082186 | MODIFICATION TO PATHWAY PV ATHERECTOMY SYSTEM | Pathway Medical Technologies, Inc. | 2008-08-29 | 28 | 0 |
| K081328 | PATHWAY PV ATHERECTOMY SYSTEM | Pathway Medical Technologies, Inc. | 2008-07-17 | 66 | 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