Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medical Specialties, Inc. · Predicate Candidate Screening
40 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
50 daysmedian FDA review time
84 days90th percentile
40clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K946201 | STAND, INFUSION | Medical Specialties, Inc. | 1995-04-18 | 118 | 0 |
| K931947 | CHECKPOINT | Medical Specialties, Inc. | 1993-06-18 | 60 | 0 |
| K926095 | REFRACTROL-SP | Medical Specialties, Inc. | 1993-01-26 | 55 | 0 |
| K924926 | MSI-HCT | Medical Specialties, Inc. | 1993-01-07 | 99 | 0 |
| K896566 | MODIFIED FOX EXTRA GRAM NEGATIVE AND POSITIVE | Medical Specialties, Inc. | 1990-02-09 | 81 | 0 |
| K883850 | MSI-CAL 16 | Medical Specialties, Inc. | 1988-11-22 | 84 | 0 |
| K883703 | MSI-CAL 7 | Medical Specialties, Inc. | 1988-11-22 | 84 | 0 |
| K883851 | MSI-CAL 8 | Medical Specialties, Inc. | 1988-11-22 | 84 | 0 |
| K880608 | MSI-PC | Medical Specialties, Inc. | 1988-03-21 | 38 | 0 |
| K880270 | MSI-DIFF PLUS | Medical Specialties, Inc. | 1988-03-01 | 40 | 0 |
| K872140 | (MSI) PATH-SAVER | Medical Specialties, Inc. | 1987-06-15 | 13 | 0 |
| K871067 | MSI HEMATOLOGY CONTROL + | Medical Specialties, Inc. | 1987-03-25 | 7 | 0 |
| K860501 | FLAME PHOTOMETER STANDARD | Medical Specialties, Inc. | 1986-04-07 | 55 | 0 |
| K853776 | MSI-HB HEMOGLOBIN CONTROL | Medical Specialties, Inc. | 1985-09-19 | 9 | 0 |
| K841069 | SERUM TOTAL PROTEIN REAGENT SET | Medical Specialties, Inc. | 1984-05-01 | 50 | 0 |
| K841049 | URIC ACID REAGENT SET ENZYMATIC | Medical Specialties, Inc. | 1984-05-01 | 50 | 0 |
| K841070 | CREATININE REAGENT SET | Medical Specialties, Inc. | 1984-05-01 | 50 | 0 |
| K841062 | TRIGLYCERIDE REAGENT SET | Medical Specialties, Inc. | 1984-05-01 | 50 | 0 |
| K841058 | LDH-UV REAGENT SET | Medical Specialties, Inc. | 1984-05-01 | 50 | 0 |
| K841054 | DIRECT GLUCOSE REAGENT SET | Medical Specialties, Inc. | 1984-05-01 | 50 | 0 |
| K841060 | SGPT REAGENT SET | Medical Specialties, Inc. | 1984-05-01 | 50 | 0 |
| K841052 | CHOLESTEROL REAGENT SET | Medical Specialties, Inc. | 1984-05-01 | 50 | 0 |
| K841053 | CHOLESTEROL REAGENT SET ENZYMATIC | Medical Specialties, Inc. | 1984-05-01 | 50 | 0 |
| K841063 | ALBUMIN REAGENT SET | Medical Specialties, Inc. | 1984-05-01 | 50 | 0 |
| K841066 | SGOT-UV REAGENT SET | Medical Specialties, Inc. | 1984-05-01 | 50 | 0 |
| K841064 | ALKALINE PHOSPHOTASE REAGENT SET | Medical Specialties, Inc. | 1984-05-01 | 50 | 0 |
| K841067 | URIC ACID REAGENT SET | Medical Specialties, Inc. | 1984-05-01 | 50 | 0 |
| K841059 | SGPT REAGENT SET | Medical Specialties, Inc. | 1984-05-01 | 50 | 0 |
| K841050 | TOTAL BILIRUBIN REAGENT SET | Medical Specialties, Inc. | 1984-05-01 | 50 | 0 |
| K841055 | GLUCOSE ENZYMATIC REAGENT SET | Medical Specialties, Inc. | 1984-05-01 | 50 | 0 |
| K841068 | UREA NITROGEN REAGENT SET | Medical Specialties, Inc. | 1984-05-01 | 50 | 0 |
| K841061 | PHOPHORUS REAGNET SET | Medical Specialties, Inc. | 1984-05-01 | 50 | 0 |
| K841056 | HDL PRECIPITANT REAGENT SET | Medical Specialties, Inc. | 1984-05-01 | 50 | 0 |
| K841051 | SERUM CALCIUM REAGENT SET | Medical Specialties, Inc. | 1984-05-01 | 50 | 0 |
| K841065 | SGOT REAGENT SET | Medical Specialties, Inc. | 1984-05-01 | 50 | 0 |
| K841057 | HEMOGLOBIN REAGENT SET | Medical Specialties, Inc. | 1984-03-23 | 11 | 0 |
| K834043 | MSI-HC HEMATOLOGY CONTROL | Medical Specialties, Inc. | 1984-01-03 | 41 | 0 |
| K831300 | MSI-NAK-50 TEST KIT | Medical Specialties, Inc. | 1983-07-18 | 88 | 0 |
| K791831 | PROCAST | Medical Specialties, Inc. | 1979-09-24 | 6 | 0 |
| K791363 | KWIK-AWA VEST | Medical Specialties, Inc. | 1979-08-03 | 17 | 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