FDA product code · Clinical Chemistry · Class 2
JKA: Tubes, Vials, Systems, Serum Separators, Blood Collection
JKA is FDA's product code for "Tubes, Vials, Systems, Serum Separators, Blood Collection": a Class 2 device classified under 21 CFR 862.1675, reviewed by the Clinical Chemistry panel.
510(k) review time for JKA
Across 61 510(k) clearances under JKA decided from 2018-01-01 to 2026-10-06, the median was 189 days from FDA receipt to decision. Half took between 124 and 267 days, and 80% were decided within 275 days. These are past clearances, not a forecast for a new submission.
| Fastest | 29 |
|---|---|
| 25th percentile | 124 |
| Median | 189 |
| 75th percentile | 267 |
| 80th percentile | 275 |
| 90th percentile | 416 |
| Slowest | 879 |
| Year | Median days | n |
|---|---|---|
| 2019 | 181 | 6 |
| 2020 | 181 | 6 |
| 2022 | 164 | 9 |
| 2023 | 198 | 16 |
| 2024 | 240 | 6 |
| 2025 | 115 | 7 |
| 2026 (to 10-06, partial) | 250 | 6 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
JKA in the public FDA record
| 510(k) clearances, all years | 236 |
|---|---|
| Device recalls | 170 |
| Establishment listings | 747 |
| GUDID device identifiers | 1,526 |
Counts of records, not of devices or events. Adverse event reports for JKA are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite JKA
6 FDA recognized consensus standards cite JKA, among them CLSI GP44-A4 (Formerly H18-A4); CLSI GP39-A6 (Formerly H01-A6); CLSI GP34-A (Replaces GP34-P). Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 7-213 CLSI GP44-A4 (Formerly H18-A4) — Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests; Approved Guideline-Fourth Edition
- 7-221 CLSI GP39-A6 (Formerly H01-A6) — Tubes and Additives for Venous Blood Specimen Collection; Approved Standard-Sixth Edition
- 7-225 CLSI GP34-A (Replaces GP34-P) — Validation and Verfication of Tubes for Venous and Capillary Blood Specimen Collection; Approved Guidance
- 7-277 CLSI GP41 7th Edition — Collection of Diagnostic Venous Blood Specimens
- 7-301 CLSI GP42 7th Edition — Collection of Capillary Blood Specimens
- 7-316 CLSI NBS01 7th Edition — Dried Blood Spot Specimen Collection for Newborn Screening
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.