Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medical Device Inspection Co., Inc. · Predicate Candidate Screening
30 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
106 daysmedian FDA review time
265 days90th percentile
30clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K945826 | J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK IN | Medical Device Inspection Co., Inc. | 1995-08-04 | 248 | 0 |
| K932072 | JARIT SURGICAL INSTRUMENTS | Medical Device Inspection Co., Inc. | 1994-01-11 | 258 | 0 |
| K931594 | THERA-TURN CM-1000 MATTRESS OVERLAY SYSTEM | Medical Device Inspection Co., Inc. | 1993-12-21 | 265 | 0 |
| K933578 | POWERMATIC MAT PLATFORM | Medical Device Inspection Co., Inc. | 1993-11-05 | 106 | 0 |
| K933580 | POWER WORK TABLE | Medical Device Inspection Co., Inc. | 1993-11-05 | 106 | 0 |
| K933581 | POWERMATIC TREATMENT TABLE | Medical Device Inspection Co., Inc. | 1993-11-05 | 106 | 0 |
| K933577 | POWERMATIC EXAMINATION TABLE | Medical Device Inspection Co., Inc. | 1993-09-30 | 70 | 0 |
| K922045 | SHOWER CHAIRS | Medical Device Inspection Co., Inc. | 1992-05-26 | 25 | 0 |
| K912075 | C-SECTION TRAY | Medical Device Inspection Co., Inc. | 1992-04-07 | 333 | 0 |
| K914174 | STERILE DISPOSABLE WET SKIN SCRUB TRAY | Medical Device Inspection Co., Inc. | 1992-02-24 | 159 | 1 |
| K920403 | XENON ARC ENDOSCOPE LIGHT SOURCE | Medical Device Inspection Co., Inc. | 1992-02-21 | 21 | 0 |
| K912054 | LABOR DELIVERY TRAY | Medical Device Inspection Co., Inc. | 1992-01-21 | 257 | 0 |
| K912158 | CENTRAL VENOUS CATHETER DRESSING CHANGE TRAY | Medical Device Inspection Co., Inc. | 1991-10-23 | 160 | 0 |
| K912116 | PRESSURE SORE MANAGEMENT KIT | Medical Device Inspection Co., Inc. | 1991-10-18 | 157 | 0 |
| K913643 | MUCOUS SPECIMEN TRAP | Medical Device Inspection Co., Inc. | 1991-10-10 | 57 | 0 |
| K912161 | I.V. STARR KIT | Medical Device Inspection Co., Inc. | 1991-10-08 | 145 | 0 |
| K913223 | STERILE DISPOSABLE URINE COLLECTOR & ACCESSORIES | Medical Device Inspection Co., Inc. | 1991-09-04 | 47 | 0 |
| K912159 | MAJOR SET-UP TRAY | Medical Device Inspection Co., Inc. | 1991-08-29 | 105 | 0 |
| K912105 | EYE TRAY | Medical Device Inspection Co., Inc. | 1991-08-29 | 108 | 0 |
| K912106 | ARTHROSCOPY TRAY | Medical Device Inspection Co., Inc. | 1991-08-29 | 108 | 0 |
| K912053 | OPEN HEART TRAY | Medical Device Inspection Co., Inc. | 1991-08-26 | 109 | 0 |
| K912052 | HEART CATH TRAY | Medical Device Inspection Co., Inc. | 1991-08-20 | 103 | 0 |
| K912104 | MAJOR BASIN TRAY | Medical Device Inspection Co., Inc. | 1991-08-09 | 88 | 0 |
| K912117 | LACERATION TRAY | Medical Device Inspection Co., Inc. | 1991-08-09 | 88 | 0 |
| K911081 | LATEX PATIENT EXAMINATION GLOVES | Medical Device Inspection Co., Inc. | 1991-03-21 | 10 | 0 |
| K904034 | TEMPORARY DENTAL CEMENT | Medical Device Inspection Co., Inc. | 1990-12-27 | 118 | 0 |
| K905550 | PATIENT EXAMINATION GLOVES | Medical Device Inspection Co., Inc. | 1990-12-19 | 8 | 0 |
| K902893 | TI-CORE (DENTAL COMPOSITE) | Medical Device Inspection Co., Inc. | 1990-09-06 | 66 | 0 |
| K902894 | POST CEMENT (DENTAL COMPOSITE) | Medical Device Inspection Co., Inc. | 1990-08-01 | 30 | 0 |
| K893229 | SPATULA FOR PAP SMEAR COLLECTION | Medical Device Inspection Co., Inc. | 1990-02-22 | 300 | 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