Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
J.S. Medical Assoc. · Predicate Candidate Screening
18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
99 daysmedian FDA review time
170 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K932752 | VISI-SPOT | J.S. Medical Assoc. | 1993-11-05 | 170 | 0 |
| K932688 | EYE SPOT IM TEST | J.S. Medical Assoc. | 1993-09-08 | 97 | 0 |
| K932180 | EYE SPOT CRP TEST | J.S. Medical Assoc. | 1993-08-23 | 110 | 0 |
| K932551 | ACCUTEX IM LATEX TEST | J.S. Medical Assoc. | 1993-08-09 | 75 | 0 |
| K926112 | ACCUTEX BETA-HCG TEST | J.S. Medical Assoc. | 1993-07-28 | 237 | 0 |
| K924332 | ACCUTEX CRP LATEX TEST | J.S. Medical Assoc. | 1992-12-07 | 102 | 0 |
| K924247 | ACCUTEX ASO LATEX TEST | J.S. Medical Assoc. | 1992-12-07 | 105 | 0 |
| K924036 | ACCUTEX RHEUMATIOD FACTOR (RF) LATEX TEST | J.S. Medical Assoc. | 1992-12-01 | 112 | 0 |
| K924248 | ACCUTEX SLE LATEX TEST | J.S. Medical Assoc. | 1992-11-02 | 70 | 0 |
| K924037 | ACCUTEX IM RBC TEST | J.S. Medical Assoc. | 1992-11-02 | 83 | 0 |
| K912716 | J&S IRON REAGENTS | J.S. Medical Assoc. | 1991-09-25 | 99 | 0 |
| K912717 | J&S UIBC REAGENTS | J.S. Medical Assoc. | 1991-09-25 | 99 | 0 |
| K910672 | J&S PEDIATRIC IRON SATURATING REAGENT | J.S. Medical Assoc. | 1991-04-29 | 73 | 0 |
| K900218 | J&S HDL CHOLESTEROL PRECIPITATING REAGENT | J.S. Medical Assoc. | 1990-06-18 | 152 | 0 |
| K893662 | J&S IRON SATURATING REAGENTS | J.S. Medical Assoc. | 1989-07-20 | 66 | 0 |
| K833677 | QUICK STAIN WRIGHT'S GIEMSA W/BUFF | J.S. Medical Assoc. | 1983-11-25 | 38 | 0 |
| K833665 | HEMATOLOGY WRIGHT'S-GIEMSA SATIN PACK | J.S. Medical Assoc. | 1983-11-25 | 38 | 0 |
| K833678 | HEMATOLOGY WRIGHT'S STAIN PACK | J.S. Medical Assoc. | 1983-11-25 | 38 | 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