Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Spectranetics, Inc. — Predicate Candidate Screening
17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
57 daysmedian FDA review time
179 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223472 | TightRail Guardian Motorized Dilator Sheath, 9 French (575-0 | Spectranetics, Inc. | 2022-12-15 | 28 | 0 |
| K222837 | Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power | Spectranetics, Inc. | 2022-12-08 | 79 | 0 |
| K212784 | TightRail Guardian Motorized Dilator Sheath | Spectranetics, Inc. | 2022-08-24 | 357 | 0 |
| DEN210024 | CavaClear Laser Sheath | Spectranetics, Inc. | 2021-12-21 | 179 | 0 |
| K203540 | Bridge Occlusion Balloon | Spectranetics, Inc. | 2020-12-23 | 20 | 0 |
| K180694 | Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power | Spectranetics, Inc. | 2018-04-05 | 20 | 0 |
| K172687 | Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power | Spectranetics, Inc. | 2017-11-27 | 82 | 0 |
| K170059 | Spectranetics Turbo-Elite Laser Atherectomy Catheters | Spectranetics, Inc. | 2017-04-07 | 91 | 3 |
| K162561 | Turbo-Power (2.0mm) Laser Atherectomy Catheters | Spectranetics, Inc. | 2017-01-05 | 113 | 0 |
| K161333 | TightRail Sub-C Rotating Dilator Sheath | Spectranetics, Inc. | 2016-07-08 | 57 | 0 |
| K153530 | Bridge Occlusion Balloon | Spectranetics, Inc. | 2016-02-05 | 58 | 1 |
| K152181 | Turbo-Power Laser Atherectomy Catheter | Spectranetics, Inc. | 2015-11-12 | 100 | 1 |
| K150360 | TightRail Rotating Dilator Sheath, TightRail Mini Rotating D | Spectranetics, Inc. | 2015-03-04 | 20 | 0 |
| K150201 | Quick-Cross Extreme Support Catheter, Quick-Cross Select Sup | Spectranetics, Inc. | 2015-02-27 | 29 | 0 |
| K142546 | TightRail Rotating Dilator Sheath/TightRail Mini Dilator She | Spectranetics, Inc. | 2014-09-25 | 15 | 0 |
| K142116 | LLD EZ | Spectranetics, Inc. | 2014-08-12 | 8 | 0 |
| K141131 | TIGHTRAIL MINI | Spectranetics, Inc. | 2014-05-23 | 22 | 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