Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
IXY · Predicate Candidate Screening
21 FDA 510(k) clearances under this product code; the 50 most recent screened below.
56 daysmedian FDA review time
145 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K953336 | VRS 3 WALL STAND | Philips Medical Systems (Cleveland), Inc. | 1995-08-11 | 25 | 0 |
| K953402 | UNIVERSIX 190 | Philips Medical Systems (Cleveland), Inc. | 1995-08-11 | 22 | 0 |
| K946114 | SENSORI-MOTOR RATING SCALE | Cmed | 1995-04-28 | 134 | 0 |
| K946260 | NTBS-1417, 1436, TBS-1417 | Scott Imaging Intl., Inc. | 1995-03-31 | 108 | 0 |
| K930230 | RADIOGRAPHIC WALL-MOUNTED CASSETTE HOLDER | American Medical Sales, Inc. | 1993-04-27 | 98 | 0 |
| K930249 | BC/WT/PF | Tingle X-Ray Products, Inc. | 1993-04-27 | 98 | 0 |
| K925934 | WALL BUCKY HOLDERS LT. & RT. HAND, & CENTER MOUNT | Continental X-Ray Corp. | 1993-03-04 | 104 | 0 |
| K924445 | BA-4 WALL BUCKY AND BA-42 TILTING WALL BUCKY | Control-X, Inc. | 1993-02-19 | 171 | 0 |
| K922443 | VERT-X UNIVERSAL VERTICAL BUCKY STAND | Afp Imaging Corp. | 1992-10-26 | 157 | 0 |
| K915667 | MODEL H170 PEDIATRIC CHEST X-RAY UNIT | H.L. Lyons Co. | 1992-01-31 | 44 | 0 |
| K895034 | BUCKYS MODELS YMB-15A, YMB-15B AND YMB-15C | Yamato Medical Corp. | 1989-11-15 | 99 | 0 |
| K891395 | RADKOR BS-10 AND BS-10T | Radkor, Inc. | 1989-04-03 | 20 | 0 |
| K872132 | SOPHY SERIES OF NUCLEAR MEDICINE COMPUTER SYSTEMS | Sopha Medical Systems, Inc. | 1987-10-26 | 145 | 0 |
| K862828 | BSX BUCKY-STAND | Garrels X-Ray Products, Inc. | 1986-08-01 | 7 | 0 |
| K860454 | BASICAM S COUNTER BALANCE CAMERA | Siemens Gammasonics, Inc. | 1986-02-21 | 16 | 0 |
| K853756 | DYNAMIC CARDIAC PHANTOM 74-347 | Victoreen, Inc. | 1985-10-29 | 50 | 0 |
| K851440 | RDIOGRAPHIC WALL HOLDER OR FILM RECEPTOR | Summit Industries, Inc. | 1985-06-05 | 56 | 0 |
| K850125 | MULTI-SIZE CASSETTE HOLDER | Philips Medical Systems (Cleveland), Inc. | 1985-03-26 | 71 | 0 |
| K810194 | WALL CASSETTE HOLDER - TRAC44 | Philips Medical Systems (Cleveland), Inc. | 1981-02-25 | 33 | 0 |
| K791916 | PELICAN BAY KEL-COR CEPHALOMETRIC SYS. | Pelican Bay Kel-Cor | 1979-11-05 | 41 | 0 |
| K790742 | KS-78 VERTICAL WALL CASSETTE HOLDER | Pausch Corp. | 1979-04-26 | 10 | 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