Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KXJ — Predicate Candidate Screening
31 FDA 510(k) clearances under this product code; the 50 most recent screened below.
42 daysmedian FDA review time
92 days90th percentile
31clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K050190 | APOLLO | Villa Sistemi Medicali S.P.A. | 2005-03-25 | 57 | 3 |
| K963905 | RADIOGRAPHIC ITT TABLE | X-Ray Technologies, Inc. | 1996-11-12 | 43 | 0 |
| K955414 | XRT 400 | Wuestec Medical, Inc. | 1996-07-24 | 240 | 0 |
| K951146 | IMAGING TABLE | Septa Corp. | 1995-05-04 | 52 | 0 |
| K950068 | CARBON FIBER COUCH INSERT | Medtec, Inc. | 1995-04-06 | 87 | 0 |
| K950442 | INFRARED EXPOSURE HAND SWITCH | Medical X-Ray Intl., Inc. | 1995-03-31 | 63 | 0 |
| K940696 | SYNCRA TILT OPTION FOR ANGIO DIAGNOST 5 | Philips Medical Systems North America, Inc. | 1994-03-16 | 28 | 0 |
| K931724 | ELECTROPHYSIOLOGY (EP) TABLE EP 2000 SERIES | Continental X-Ray Corp. | 1993-06-14 | 82 | 0 |
| K926407 | MODEL COLE TAB-2 TABLE W/MODEL COLE SFD-2 SPOTFILM | Nucletron-Oldelft Corp. | 1993-03-31 | 100 | 0 |
| K922098 | CAG-02A | Toshiba America Medical Systems, In.C | 1992-07-27 | 82 | 0 |
| K913121 | OMNIFLEX OVERHEAD TUBECRANE CAT.#S-9108/#6713.400 | Continental X-Ray Corp. | 1991-08-16 | 31 | 0 |
| K883885 | RADKOR, RF-159 | Radkor, Inc. | 1988-10-19 | 36 | 0 |
| K883155 | RASTIX X-RAY TABLE | Bay X-Ray, Inc. | 1988-09-06 | 42 | 0 |
| K881700 | RADKOR KOB-84 | Radkor, Inc. | 1988-09-02 | 136 | 0 |
| K874934 | UNIVERSAL EXAMINATION TABLE | Imatron, Inc. | 1988-01-19 | 46 | 0 |
| K874639 | REMOTE-CONTROLLED UNIVERSAL DIAG. TABLE RS-100 | Shimadzu Precision Instruments, Inc. | 1987-12-04 | 22 | 0 |
| K871827 | OMEGA III ANGIOGRAPHIC TABLE, ROTATION & STEPPER | General Electric Co. | 1987-06-19 | 39 | 0 |
| K862144 | X-MAT | Combined Concepts, Inc. | 1986-06-25 | 21 | 0 |
| K860620 | SHAMPAINE RADI-OP MODEL 1700RC | Smith & Nephew, Inc. | 1986-04-08 | 48 | 0 |
| K854328 | MEDEX X-RAY TABLE | Philips Medical Systems (Cleveland), Inc. | 1986-01-28 | 92 | 0 |
| K834478 | CHICK/REISON PATIENT EMERG. TROLLEY | Professional Medical Products, Inc. | 1984-02-21 | 63 | 0 |
| K820111 | SIEMENS SIRESKOP 4 | Siemens Corp. | 1982-02-18 | 34 | 0 |
| K812791 | PORTABLE MEDICAL TABLE | Richard D. Spradlin | 1981-11-24 | 49 | 0 |
| K811969 | DUAL PEDESTAL TABLE | Philips Medical Systems (Cleveland), Inc. | 1981-08-13 | 34 | 0 |
| K811196 | ALLMEC 90/15 | Tecnomed, Inc. | 1981-06-09 | 40 | 0 |
| K803120 | TILTING IMAGING TABLE #846T | Quinton, Inc. | 1981-01-22 | 42 | 0 |
| K790783 | KOORDINAT 3D | Siemens Corp. | 1979-05-07 | 14 | 0 |
| K790743 | COORDINATUS, HORIZONTAL RADIOGRAPHOC | Pausch Corp. | 1979-04-23 | 7 | 0 |
| K790692 | TELEVIX | General Electrical Espanola, S.A. | 1979-04-23 | 13 | 1 |
| K790536 | CLEARVIEW | Hipoint Research, Inc. | 1979-03-28 | 6 | 0 |
| K781992 | KOORDINAT ANGIO | Siemens Corp. | 1978-12-07 | 13 | 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