Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biodan Medical Systems, Ltd. · Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
69 daysmedian FDA review time
140 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K932153 | THYROID UPTAKE SYSTEM & ATOMLAB 950 MED. SPECTROME | Biodan Medical Systems, Ltd. | 1993-09-07 | 126 | 0 |
| K930261 | RTM REHABILITATION TREADMILL, MODEL #945-200 | Biodan Medical Systems, Ltd. | 1993-05-26 | 127 | 0 |
| K930262 | TREATMENT TABLE, MODEL #825-100 | Biodan Medical Systems, Ltd. | 1993-03-29 | 69 | 0 |
| K930259 | TRACTION TABLE MODEL #825-200 | Biodan Medical Systems, Ltd. | 1993-03-24 | 64 | 0 |
| K926083 | NUCLEAR PATIENT SANNING TABLES, VARIOUS TYPES | Biodan Medical Systems, Ltd. | 1993-02-12 | 73 | 0 |
| K926082 | CARDIAC STRESS TABLE, 056-180/UNIV ROLL STRESS ATT | Biodan Medical Systems, Ltd. | 1992-12-30 | 29 | 0 |
| K922591 | UROLOGICAL C-ARM TABLE, MODEL #056-450 | Biodan Medical Systems, Ltd. | 1992-11-27 | 178 | 0 |
| K922604 | DELUXE ADJUSTABLE HEIGHT ULTRASOUND TABLE | Biodan Medical Systems, Ltd. | 1992-10-20 | 140 | 0 |
| K922605 | TRENDELENBURG ULTRASOUND TABLE, MODEL # 056-603 | Biodan Medical Systems, Ltd. | 1992-10-20 | 140 | 0 |
| K923350 | CLOSED CHAIN ATTACHMENT, MODEL #820-520 | Biodan Medical Systems, Ltd. | 1992-07-23 | 15 | 0 |
| K922772 | TWO POSITION ROLL-UP BACK ATTACHMENT CHAIR | Biodan Medical Systems, Ltd. | 1992-07-13 | 34 | 0 |
| K922606 | MULTI JOINT WEIGHT SYSTEM MODEL #940-100 | Biodan Medical Systems, Ltd. | 1992-06-19 | 17 | 0 |
| K922602 | CABLE COLUMN WEIGHT SYSTEM MODEL #940-200 | Biodan Medical Systems, Ltd. | 1992-06-19 | 17 | 0 |
| K922603 | TOTAL WORK INTEGRATOR, MODEL #940-110 | Biodan Medical Systems, Ltd. | 1992-06-19 | 17 | 0 |
| K922092 | SINGLE CHAIR INTEGRAL BACK ATTACHMENT | Biodan Medical Systems, Ltd. | 1992-05-26 | 21 | 0 |
| K921501 | DELUXE C ARM RADIOLOGICAL TABLE, MODEL #056-004 | Biodan Medical Systems, Ltd. | 1992-05-15 | 45 | 0 |
| K900770 | HOME URODATA SYSTEM(TM) | Biodan Medical Systems, Ltd. | 1990-06-08 | 112 | 0 |
| K840088 | BIODEX ACT-O-KIT TSH-RIA- | Biodan Medical Systems, Ltd. | 1984-05-07 | 118 | 0 |
| K832896 | LEGIONELLA INDIRECT FLUORESCENT ANTIBOD | Biodan Medical Systems, Ltd. | 1983-10-14 | 52 | 0 |
| K822066 | LEGIONELLA PNEUMOPHILA | Biodan Medical Systems, Ltd. | 1982-09-21 | 69 | 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