Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Radionics, Inc. — Predicate Candidate Screening
56 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
85 daysmedian FDA review time
371 days90th percentile
56clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K030697 | RADIONICS SINGLE USE GROUND PAD (DGP-HP) | Radionics, Inc. | 2003-04-04 | 29 | 1 |
| K002773 | NEUROMAP WITH NEURO 100 | Radionics, Inc. | 2000-10-23 | 47 | 0 |
| K001741 | RADIONICS RF DISC CATHETER ELECTRODE SYSTEM | Radionics, Inc. | 2000-10-23 | 137 | 0 |
| K992226 | XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM | Radionics, Inc. | 2000-08-04 | 399 | 0 |
| K001950 | OPTICAL TRACKING SYSTEM (OTS) | Radionics, Inc. | 2000-07-26 | 29 | 0 |
| K001700 | XPLAN 2.1 | Radionics, Inc. | 2000-06-28 | 23 | 0 |
| K001431 | MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) | Radionics, Inc. | 2000-05-17 | 9 | 0 |
| K000057 | RADIONICS LUMBOPERITONEAL SHUNT | Radionics, Inc. | 2000-03-20 | 70 | 0 |
| K993594 | CONFORMAX MMLC VR1 | Radionics, Inc. | 1999-12-15 | 51 | 0 |
| K991399 | RADIONICS MICROELECTRODE KIT | Radionics, Inc. | 1999-09-21 | 152 | 0 |
| K992721 | COSMAN ROBERT WELLS FUNCTIONAL PROBE MICRODRIVE | Radionics, Inc. | 1999-09-10 | 28 | 0 |
| K992379 | RADIONICS XDC EXTERNAL VENTRICULAR CATHETER | Radionics, Inc. | 1999-09-08 | 54 | 0 |
| K991237 | XPLAN-2 WITH HEAD AND NECK LOCALIZER, MODEL HNL | Radionics, Inc. | 1999-08-30 | 140 | 1 |
| K991523 | TLC PEDIATRIC FRAME, MODEL TLC-SYS | Radionics, Inc. | 1999-07-30 | 88 | 0 |
| K990632 | OPTICAL TRACKING SYSTEM (OTS) | Radionics, Inc. | 1999-04-29 | 62 | 0 |
| K980903 | RADIONICS EQUI-FLOW VALVE, VENTRICULAR AND PERITONEAL CATHET | Radionics, Inc. | 1999-04-19 | 405 | 0 |
| K984552 | COOL-TIP RF SYSTEM | Radionics, Inc. | 1999-03-05 | 73 | 1 |
| K990071 | IMAGEFUSION 2.0 | Radionics, Inc. | 1999-02-08 | 28 | 0 |
| K982549 | RADIONICS MINI MULTI-LEAF COLLIMATOR, MODEL RADIONICS MMLC | Radionics, Inc. | 1998-12-30 | 162 | 0 |
| K984245 | NON-INVASIVE DYNAMIC REFERENCE FRAME (DRF) FOR OPTICAL TRACK | Radionics, Inc. | 1998-12-18 | 21 | 0 |
| K981820 | NEUROMAP | Radionics, Inc. | 1998-11-20 | 182 | 0 |
| K983669 | OPTICAL TRACKING SYSTEM WITH SURFACE MATCHING MODULE, MODEL | Radionics, Inc. | 1998-11-18 | 30 | 0 |
| K983603 | REFLECTIVE SPHERE STANDARD PROBE AND REFLECTIVE SPHERE DYNAM | Radionics, Inc. | 1998-11-10 | 27 | 0 |
| K981597 | RADIONICS SLICE EDITOR IMAGING SOFTWARE UTILITY | Radionics, Inc. | 1998-10-09 | 158 | 0 |
| K982489 | RFG-3C PLUS | Radionics, Inc. | 1998-10-05 | 80 | 0 |
| K981055 | XKNIFE-4 | Radionics, Inc. | 1998-09-29 | 190 | 0 |
| K982364 | WIRELESS STANDARD PROBE, DYNAMIC REFERENCE FRAME (DRF) | Radionics, Inc. | 1998-08-05 | 30 | 0 |
| K981213 | UNIVERSAL INSTRUMENT REGISTRATION (UIR) MICROSCOPE MODULE I | Radionics, Inc. | 1998-07-01 | 90 | 0 |
| K980584 | ATLASPLAN | Radionics, Inc. | 1998-05-18 | 90 | 0 |
| K980448 | MODEL PS-1 PENA MUSCLE STIMULATOR | Radionics, Inc. | 1998-04-03 | 57 | 0 |
| K980430 | RADIONICS DISPOSABLE RF CANNULAE (SC-C, RFK-DB, RFK-DS) | Radionics, Inc. | 1998-03-16 | 40 | 0 |
| K973297 | COSMAN COAGULATOR (CC-1) SYSTEM | Radionics, Inc. | 1997-10-29 | 57 | 1 |
| K961942 | EPIDURAL PEG ELECTRODE (EP), SPHENOIDAL ELECTRODE (EDS) AND | Radionics, Inc. | 1997-08-18 | 455 | 0 |
| K971511 | RADIONICS CONTOUR FLEX VALVE, RADIONICS CONTOUR FLEX PLUS VA | Radionics, Inc. | 1997-07-24 | 87 | 0 |
| K970578 | RADIONICS BURR HOLE VALVE | Radionics, Inc. | 1997-06-04 | 110 | 0 |
| K965182 | RFG-3CF | Radionics, Inc. | 1997-03-12 | 78 | 0 |
| K964386 | RADIONICS CONTOUR FLEX PLUS VALVE | Radionics, Inc. | 1997-01-31 | 88 | 0 |
| K963577 | RADIONICS SLUIJTER-MEHTA CANNULA | Radionics, Inc. | 1996-11-21 | 76 | 0 |
| K963579 | PACE-1A CARDIAC STIMULATOR | Radionics, Inc. | 1996-11-08 | 63 | 0 |
| K962990 | RADIONICS SIPHON LIMITING DEVICE (SLD) | Radionics, Inc. | 1996-10-23 | 83 | 0 |
| K961858 | COSGROVE DEPTH ELECTRODE KIT(CDEK) | Radionics, Inc. | 1996-08-07 | 85 | 0 |
| K954285 | CONTOUR FLEX VALVES (REGULAR & SMALL) | Radionics, Inc. | 1996-01-26 | 134 | 0 |
| K934523 | GILL-THOMAS-COSMAN (GTC) RELOCATABLE HEAD HOLDER SYSTEM WITH | Radionics, Inc. | 1995-02-08 | 509 | 0 |
| K940466 | TITANIUM BIPOLAR FORCEPS | Radionics, Inc. | 1994-04-21 | 78 | 0 |
| K923697 | RADIONUCLIDE CATHETERS, RNC-A, RNC-G, RNC-U | Radionics, Inc. | 1993-12-13 | 507 | 0 |
| K926424 | CORTICAL SURF EPILEPSY ELECT DEPTH ELEC EPILEP MON | Radionics, Inc. | 1993-11-19 | 331 | 0 |
| K934391 | V/P AND L/P CATHETER PASSERS | Radionics, Inc. | 1993-11-19 | 71 | 0 |
| K924226 | OJEMANN CORTICAL STIMULATOR | Radionics, Inc. | 1993-04-21 | 243 | 1 |
| K924632 | LCM-2-LINAC COUCH-MOUNT SYSTEM | Radionics, Inc. | 1993-04-07 | 205 | 0 |
| K923647 | RFG-DGP DISPOSABLE GROUNDING PADS | Radionics, Inc. | 1992-11-09 | 111 | 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