Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
ClearStream Technologies , Ltd. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
86 daysmedian FDA review time
135 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K112335 | BANTAM CATHETER (280MM BALLOON LENGTHS) | ClearStream Technologies , Ltd. | 2011-10-12 | 61 | 0 |
| K102035 | SLEEK OTW PTA CATHETERS | ClearStream Technologies , Ltd. | 2010-12-01 | 135 | 0 |
| K101361 | REEFLEX PTA CATHETER | ClearStream Technologies , Ltd. | 2010-08-04 | 82 | 0 |
| K100490 | LITEPAC, MODEL 682 | ClearStream Technologies , Ltd. | 2010-03-16 | 25 | 0 |
| K093139 | BANTAM,48XXXXXX, 50XXXXXX | ClearStream Technologies , Ltd. | 2009-12-30 | 86 | 0 |
| K083596 | REEKROSS FAMILY OR OTW PTA CATHETERS | ClearStream Technologies , Ltd. | 2009-03-02 | 87 | 0 |
| K072947 | SAVVY LONG AND SLEEK PERIPHERAL TRANSLUMINAL ANGIOPLASTY (PT | ClearStream Technologies , Ltd. | 2008-02-08 | 113 | 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