Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medi-Tech, Inc. — Predicate Candidate Screening
36 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
68 daysmedian FDA review time
233 days90th percentile
36clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K954457 | MEDI-TECH EDDY INTRAVASCULAR INFUSION CATHETER | Medi-Tech, Inc. | 1996-05-15 | 233 | 0 |
| K952345 | MEDI-TECH PLATFORM GUIDE CATHETER | Medi-Tech, Inc. | 1995-08-17 | 90 | 0 |
| K952056 | IMMUNOASSAY DRUGS OF ABUSE CONTROLS | Medi-Tech, Inc. | 1995-06-01 | 30 | 0 |
| K945289 | DOA - IMMUNOASSAY CUT-OFF CALIBRATOR | Medi-Tech, Inc. | 1994-12-13 | 43 | 0 |
| K942551 | THERAPEUTIC DRUG MONITORING CONTROL, ASSAYED | Medi-Tech, Inc. | 1994-10-06 | 128 | 0 |
| K943290 | BILIRUBIN PLUS/PEDIATRIC CONTROLS | Medi-Tech, Inc. | 1994-09-14 | 68 | 0 |
| K922990 | HEMODIALYSIS BATH | Medi-Tech, Inc. | 1994-09-12 | 812 | 0 |
| K942552 | THERAPEUTIC DRUG MONITORING CONTROL, UNASSAYED | Medi-Tech, Inc. | 1994-09-09 | 101 | 0 |
| K904073 | COAGULATION REFERENCE PLASMA, ABNORMAL | Medi-Tech, Inc. | 1990-10-22 | 47 | 0 |
| K895819 | MODIFIED LABELING TO THE SPAND-GEL GRANULATED GEL | Medi-Tech, Inc. | 1989-11-02 | 34 | 0 |
| K873295 | PROSTATIC URETHRO. BALLOON DILATATION CATHETER | Medi-Tech, Inc. | 1989-07-31 | 714 | 0 |
| K884354 | IMAGER FLUSH CATHETERS | Medi-Tech, Inc. | 1989-04-21 | 186 | 0 |
| K883880 | KATZEN THROMBOLYSIS GUIDEWIRE | Medi-Tech, Inc. | 1989-04-06 | 205 | 2 |
| K884513 | PF TEST | Medi-Tech, Inc. | 1989-02-03 | 99 | 0 |
| K874096 | TITANIUM GREENFIELD VENA CAVA FILTER CARRIER | Medi-Tech, Inc. | 1988-11-04 | 393 | 0 |
| K883118 | ON THE SPOT CANDIDASURE | Medi-Tech, Inc. | 1988-09-30 | 67 | 0 |
| K880298 | PERIPHERAL DILATATION CATHETER | Medi-Tech, Inc. | 1988-04-22 | 88 | 0 |
| K864118 | MEDI-TECH SELECTIVE TORQUE CATHETER | Medi-Tech, Inc. | 1987-04-09 | 170 | 0 |
| K870729 | TITANIUM PERCUTANEOUS GREENFIELD VENA CAVE FILTER | Medi-Tech, Inc. | 1987-04-09 | 43 | 0 |
| K861599 | T-FASTENER | Medi-Tech, Inc. | 1986-10-02 | 156 | 0 |
| K852097 | PERCUTANEOUS GREENFIELD VENA CAVA FILTER SYSTEM | Medi-Tech, Inc. | 1985-11-01 | 170 | 0 |
| K852552 | COONS GASTROSTICK SYSTEM | Medi-Tech, Inc. | 1985-10-17 | 122 | 0 |
| K851402 | LEVEEN INFLATOR DISPOSABLE INFLATION SYRINGE | Medi-Tech, Inc. | 1985-06-10 | 62 | 0 |
| K843012 | WIREGUIDE OR GUIDEWIRE | Medi-Tech, Inc. | 1984-11-29 | 121 | 0 |
| K844292 | MEDI-TECH DILATATION CATHETERS | Medi-Tech, Inc. | 1984-11-23 | 18 | 0 |
| K843383 | MEDI-TECH DILATATION CATHETERS | Medi-Tech, Inc. | 1984-10-24 | 57 | 0 |
| K842890 | PERCUFIX CATHETER CUFF | Medi-Tech, Inc. | 1984-09-04 | 43 | 0 |
| K842205 | OXY-VAC | Medi-Tech, Inc. | 1984-06-25 | 21 | 0 |
| K830483 | COONS SOFT STENT | Medi-Tech, Inc. | 1983-03-09 | 22 | 0 |
| K821816 | ANGIOGRAPHIC CATHETER | Medi-Tech, Inc. | 1982-08-24 | 64 | 0 |
| K821348 | HYPODERMIC NEEDLES & SYRINGES | Medi-Tech, Inc. | 1982-06-10 | 36 | 0 |
| K812279 | ENTER-A1 ENTERIC FEEDING TUBE | Medi-Tech, Inc. | 1981-08-25 | 12 | 0 |
| K811378 | PERCUTANEOUS DRAINING CATHETER | Medi-Tech, Inc. | 1981-06-02 | 18 | 5 |
| K810336 | POLYPECTOMY SNARE | Medi-Tech, Inc. | 1981-03-20 | 39 | 0 |
| K781772 | CATHETER, TRANSLUMINAL BALLOON | Medi-Tech, Inc. | 1979-03-06 | 141 | 0 |
| K781780 | CATHETER, EXTERNAL MALE NURSING CARE | Medi-Tech, Inc. | 1978-12-07 | 50 | 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