Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Integra Radionics, Inc. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
59 daysmedian FDA review time
304 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K102258 | CUSA NXT EXTENDED LENGTH TIP | Integra Radionics, Inc. | 2011-06-10 | 304 | 0 |
| K100096 | LINAC COLLIMATOR ASSEMBLY HOUSING (LCAH) MODEL LCAHART | Integra Radionics, Inc. | 2010-04-22 | 99 | 0 |
| K100417 | XKNIFE 5 | Integra Radionics, Inc. | 2010-04-08 | 51 | 1 |
| K090864 | CUSA SHEAR TIP, AN ACCESSORY OF THE CUSA EXCEL ULTRASONIC SU | Integra Radionics, Inc. | 2009-05-08 | 39 | 0 |
| K083414 | RADIONICS XKNIFE HDRT SYSTEM | Integra Radionics, Inc. | 2009-03-02 | 104 | 0 |
| K081459 | CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM | Integra Radionics, Inc. | 2008-08-13 | 82 | 4 |
| K072454 | INTEGRA RADIONICS INTERFIX PATIENT ADAPTERS | Integra Radionics, Inc. | 2007-10-16 | 46 | 1 |
| K071669 | INTEGRA SELECTOR ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH B | Integra Radionics, Inc. | 2007-08-17 | 59 | 0 |
| K063230 | INTEGRA RADIONICS IMAGEFUSION 3 | Integra Radionics, Inc. | 2006-12-21 | 57 | 0 |
| K061893 | INTEGRA RADIONICS XKNIFE RT 4 | Integra Radionics, Inc. | 2006-07-25 | 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