Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medical Devices, Inc. · Predicate Candidate Screening
49 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
80 daysmedian FDA review time
252 days90th percentile
49clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K002280 | PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602 | Medical Devices, Inc. | 2001-02-05 | 194 | 1 |
| K930084 | MICRO-ARTHROSCOPE | Medical Devices, Inc. | 1995-09-01 | 967 | 0 |
| K940012 | SMARTBRACE ELECTRODE | Medical Devices, Inc. | 1994-12-05 | 335 | 0 |
| K943126 | ELECTROFLEX | Medical Devices, Inc. | 1994-12-05 | 159 | 0 |
| K935132 | HOME MICROCURRENT HMC | Medical Devices, Inc. | 1994-03-14 | 137 | 0 |
| K934619 | FLEXMATE | Medical Devices, Inc. | 1994-02-23 | 149 | 0 |
| K924897 | XENON ENDOSCOPIC ILLUMINATOR, MODEL XEI-300 | Medical Devices, Inc. | 1993-07-06 | 280 | 0 |
| K930053 | VIDEO CAMERA W/ ELECTRONIC SHUTTER MODEL VCE-10 | Medical Devices, Inc. | 1993-05-17 | 131 | 0 |
| K923914 | IF-II (TM), MODEL 7200 | Medical Devices, Inc. | 1992-11-06 | 98 | 0 |
| K920071 | MEDITRON AUTOMATIC ELECTRONIC INSUFF. MODEL AEI-15 | Medical Devices, Inc. | 1992-07-21 | 196 | 0 |
| K915694 | MEDITRON ELECTRONIC LAPAROSCOPIC INSUFFLATOR | Medical Devices, Inc. | 1992-06-18 | 178 | 0 |
| K915408 | BIPOLAR ENDOSTASIS PROBE, BEST (TM) | Medical Devices, Inc. | 1992-03-11 | 100 | 0 |
| K912182 | MEDITRON COMBINATION GENERATOR CG-2000 | Medical Devices, Inc. | 1991-09-06 | 113 | 0 |
| K912348 | SX90 (TM),MODEL 4800S | Medical Devices, Inc. | 1991-06-24 | 27 | 0 |
| K905133 | STYLET TRACHAEL TUBE | Medical Devices, Inc. | 1991-04-22 | 158 | 0 |
| K903161 | MC II (TM), MODEL 7200S | Medical Devices, Inc. | 1991-03-27 | 252 | 0 |
| K901302 | BIPOLARD POLYPECTOMY SYSTEM (TM) | Medical Devices, Inc. | 1990-06-06 | 78 | 0 |
| K895473 | DSX(TM), DIGITAL SX, QUANTUM DSX, MODEL 4700S | Medical Devices, Inc. | 1989-12-08 | 88 | 0 |
| K883462 | IF-II (TM), MODEL 9800 | Medical Devices, Inc. | 1989-05-24 | 282 | 0 |
| K890705 | MEDIMOD(TM), MODEL 8900 | Medical Devices, Inc. | 1989-03-09 | 27 | 0 |
| K882888 | MULTIDAY, MODELS 8300 AND 8310 | Medical Devices, Inc. | 1988-09-30 | 81 | 0 |
| K882887 | PROGEL(TM), MODELS 8630 AND 8635 | Medical Devices, Inc. | 1988-09-29 | 80 | 0 |
| K882886 | PROGEL (TM) DUAL ELECTRODE PAD, MODEL 8535 | Medical Devices, Inc. | 1988-09-29 | 80 | 0 |
| K882820 | MEDIPAC II EC (TM), MODEL 7900 | Medical Devices, Inc. | 1988-08-29 | 52 | 0 |
| K881082 | GV 11 (TM), MODEL 9700 | Medical Devices, Inc. | 1988-03-28 | 14 | 0 |
| K872753 | MYOSTIM(TM), MODEL 6600 | Medical Devices, Inc. | 1987-10-01 | 80 | 0 |
| K872657 | ULTRAPAC II SX PLUS (TM) | Medical Devices, Inc. | 1987-08-04 | 28 | 0 |
| K864968 | BACPAC (TM), MODEL 6500 | Medical Devices, Inc. | 1987-03-13 | 81 | 0 |
| K864625 | MYOPAC (TM), MODEL 9600 | Medical Devices, Inc. | 1986-12-29 | 34 | 0 |
| K862337 | ULTRAPAC II SD (TM) | Medical Devices, Inc. | 1986-08-18 | 59 | 0 |
| K862028 | ULTRAHESIVE II POSTOP ELECTRODE | Medical Devices, Inc. | 1986-08-01 | 65 | 0 |
| K861012 | SILENT PARTNER MODEL 10-1001 | Medical Devices, Inc. | 1986-04-04 | 17 | 0 |
| K861011 | SILENT PARTNER MODEL 10-2001 | Medical Devices, Inc. | 1986-04-04 | 17 | 0 |
| K854316 | FASTENS(TM) | Medical Devices, Inc. | 1986-02-28 | 123 | 0 |
| K854761 | MINIPAC PERSONAL TOUCH (TM) | Medical Devices, Inc. | 1986-02-14 | 79 | 0 |
| K854317 | MINIPAC (TM) | Medical Devices, Inc. | 1986-01-21 | 85 | 0 |
| K851175 | TRANSCUTANEOUS ELECTRICAL NERVE STIMULA-ELECTORDE | Medical Devices, Inc. | 1985-06-18 | 85 | 0 |
| K831413 | SPEC IISX | Medical Devices, Inc. | 1983-06-08 | 37 | 0 |
| K821979 | STERILE FOLEY CATHETERIZATION KITS | Medical Devices, Inc. | 1982-08-30 | 55 | 0 |
| K821978 | STERILE URETHRAL CATHETERIZATION SET | Medical Devices, Inc. | 1982-08-25 | 50 | 0 |
| K810593 | NEUROPAC ULTRA I | Medical Devices, Inc. | 1981-03-13 | 8 | 0 |
| K803259 | CLOSED SYSTEM URETHRAL CATHETERIZ. SET | Medical Devices, Inc. | 1981-01-09 | 17 | 0 |
| K792312 | HEART RATE MONITOR MD-1 | Medical Devices, Inc. | 1979-11-21 | 5 | 0 |
| K792082 | GAVAGE FEEDING SET | Medical Devices, Inc. | 1979-11-13 | 28 | 0 |
| K781829 | NEUROPAC ULTRA II | Medical Devices, Inc. | 1978-11-22 | 23 | 0 |
| K780831 | URINARY CATHETERIZATION SYSTEM W/O FOLEY | Medical Devices, Inc. | 1978-07-27 | 66 | 0 |
| K780134 | URINARY DRAINAGE MONITORING SYSTEM | Medical Devices, Inc. | 1978-02-02 | 9 | 0 |
| K771779 | CATHETERIZATION SYS. URINARY DRAINAGE | Medical Devices, Inc. | 1977-10-05 | 14 | 0 |
| K770320 | URINARY DRAINAGE SET, CLOSED, STERILE | Medical Devices, Inc. | 1977-03-16 | 28 | 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