Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medical Design & Manufacturing Corp. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
58 daysmedian FDA review time
325 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K911911 | MEDICAL DESIGNS, INC. BIO-THERAPY SYSTEM | Medical Design & Manufacturing Corp. | 1992-03-20 | 325 | 0 |
| K914384 | MEDICAL DESIGNS REUSABLE CARBON RUBBER ELECTRODE | Medical Design & Manufacturing Corp. | 1991-11-13 | 43 | 0 |
| K911366 | PROTECTOR DISPOSABLE TENS AND NMES ELECTRODE | Medical Design & Manufacturing Corp. | 1991-09-27 | 183 | 0 |
| K902822 | MEDICAL DESIGNS, INC., SPECTRUM II TENS DEVICE | Medical Design & Manufacturing Corp. | 1990-12-19 | 175 | 0 |
| K895604 | SOFT-EZ REUSABLE SELF-ADHERING PIGTAIL ELECTRODES | Medical Design & Manufacturing Corp. | 1989-10-13 | 25 | 0 |
| K880492 | INTERCEPT T.E.N.S. DEVICE | Medical Design & Manufacturing Corp. | 1988-04-18 | 74 | 0 |
| K834138 | HYPO SUTURE | Medical Design & Manufacturing Corp. | 1984-01-27 | 58 | 0 |
| K821848 | ASSURE-MALE EXTERNAL INCONTINCE CATHETER | Medical Design & Manufacturing Corp. | 1982-08-10 | 49 | 0 |
| K811224 | MINISTIM | Medical Design & Manufacturing Corp. | 1981-06-02 | 29 | 0 |
| K810222 | LIMB ORHTOSIS | Medical Design & Manufacturing Corp. | 1981-02-04 | 8 | 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