Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medical Engineering Corp. — Predicate Candidate Screening
28 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
63 daysmedian FDA review time
167 days90th percentile
28clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K934141 | STAND ALONE CYSTOMETROGRAM | Medical Engineering Corp. | 1993-11-18 | 85 | 0 |
| K905289 | SURGITEK(R) LUBRI-FLEX(TM) URETERAL STENT | Medical Engineering Corp. | 1991-03-13 | 107 | 0 |
| K903448 | SURGITEK TEX-SPAN TEXTURED TISSUE EXPANDER | Medical Engineering Corp. | 1991-01-14 | 167 | 0 |
| K902773 | SURGITEK(R) FLEXIBLE URETEROSCOPY INTRO/SHEATH SET | Medical Engineering Corp. | 1990-07-16 | 21 | 0 |
| K884746 | SURGITEK FLAT T-SPAN | Medical Engineering Corp. | 1989-08-10 | 269 | 0 |
| K883274 | SURGITEK (R) UROFLOW SYSTEM | Medical Engineering Corp. | 1989-02-08 | 189 | 0 |
| K881736 | SURGITEK CO2 DELIVERY SYSTEM | Medical Engineering Corp. | 1988-08-11 | 111 | 0 |
| K880802 | SURGITEK ARTICULATING URETEROSCOPE MODEL SU-11 | Medical Engineering Corp. | 1988-05-26 | 87 | 0 |
| K880801 | SURGITEK FLEXIBLE URETEROSCOPE SU-7 & SU-9 | Medical Engineering Corp. | 1988-05-26 | 87 | 0 |
| K842748 | SURGITEK RECONSTRUC-NIPPLE PROSTHESIS | Medical Engineering Corp. | 1984-09-26 | 75 | 0 |
| K832043 | SURGIKEK PENILE PROSTHESIS TAIL EXTEND | Medical Engineering Corp. | 1983-10-20 | 118 | 0 |
| K833008 | PERCUTANEOUS NEPHROSTOMY CATHETER | Medical Engineering Corp. | 1983-10-19 | 43 | 0 |
| K831857 | SURGITEK PERCUTANEOUS ARNEGRADE SILITEK | Medical Engineering Corp. | 1983-08-11 | 63 | 0 |
| K830884 | SURGITEKS PERCUTANEOUS ANTEGRADE ALL - | Medical Engineering Corp. | 1983-05-09 | 49 | 0 |
| K823757 | SURGITEK ENDOTRACHEAL TUBE, LASER RESIS | Medical Engineering Corp. | 1983-04-28 | 135 | 0 |
| K830917 | SURGITEK SIZER FOR PENILE PROSTHESIS | Medical Engineering Corp. | 1983-04-12 | 21 | 0 |
| K830226 | SURGITEK PERCUTANEOUS NEPHROSTOMY CATH | Medical Engineering Corp. | 1983-02-09 | 16 | 0 |
| K822295 | SURGI TEK'S DISPOS. INNER CANNULA FOR | Medical Engineering Corp. | 1982-08-20 | 18 | 0 |
| K821776 | SURGITEK PERCUTANEOUS NEPHROST. STENT | Medical Engineering Corp. | 1982-08-10 | 54 | 0 |
| K803156 | SURGITEK MEDI-LOOPS | Medical Engineering Corp. | 1981-01-15 | 34 | 0 |
| K800331 | SURGITEK FOERSTER FACE LIFT DRAIN | Medical Engineering Corp. | 1980-03-05 | 21 | 0 |
| K800109 | SURGITEK URINARY DIVERSION STENT | Medical Engineering Corp. | 1980-02-26 | 41 | 0 |
| K800248 | SURGITEK FOERSTER FACE LIFT BANDAGE | Medical Engineering Corp. | 1980-02-19 | 13 | 0 |
| K800249 | SURGITEK FOERSTER MAMMARY BANDAGE | Medical Engineering Corp. | 1980-02-19 | 13 | 0 |
| K790245 | STANDARD PECTORALIS MUSCLE IMPLANT | Medical Engineering Corp. | 1979-04-04 | 57 | 0 |
| K781641 | SURGITEK DOUBLE J URETEROL STENT | Medical Engineering Corp. | 1978-12-07 | 77 | 0 |
| K781336 | SURGITEK DISPOSABLE FLO-RESTER | Medical Engineering Corp. | 1978-10-10 | 68 | 0 |
| K761328 | ANASTOMASIS OCCLUDER | Medical Engineering Corp. | 1977-02-01 | 36 | 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