FDA product code JKA: Tubes, Vials, Systems, Serum Separators, Blood Collection
JKA is the FDA product code for tubes, vials, systems, serum separators, blood collection. It is a Class II device, regulated under 21 CFR 862.1675 and reviewed by the Clinical Chemistry panel. FDA has cleared 236 510(k) submissions under JKA, 43 in the last five years, from 117 different applicants. The average 510(k) review took 144 days (median 92); 193 days on average over the last three years. FDA has posted 170 recalls for JKA devices, 26 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Device class | Class II |
| Regulation | 21 CFR 862.1675 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
510(k) clearances per year for JKA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 128 |
| 2018 | 1 | 264 |
| 2019 | 6 | 224 |
| 2020 | 6 | 146 |
| 2021 | 4 | 256 |
| 2022 | 9 | 259 |
| 2023 | 16 | 288 |
| 2024 | 6 | 213 |
| 2025 | 7 | 144 |
| 2026 | 5 | 222 |
Compare with all 510(k) review times · Search every JKA clearance
Top JKA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Becton, Dickinson and Company | 18 | 2026-04-15 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 13 | 1999-09-23 |
| Becton Dickinson Vacutainer Systems | 11 | 2000-11-02 |
| Sherwood Medical Co. | 9 | 1995-05-26 |
| Becton, Dickinson & CO | 8 | 2010-06-29 |
112 more applicants have JKA clearances. See the full list in Caduvo.
Most recent JKA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252899 | Zhejiang Kindly Medical Device Co., Ltd. | Female Culture Device; Male Culture Device; Transfer Device; Access Device | 2026-06-02 | 264 |
| K260128 | Becton, Dickinson and Company | BD Preset and BD A-Line Arterial Blood Collection Syringes | 2026-04-15 | 89 |
| K252378 | Becton, Dickinson and Company | BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood Collection Tube | 2026-04-10 | 254 |
| K252506 | Becton, Dickinson and Company | BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder | 2026-04-10 | 245 |
| K252040 | Becton, Dickinson and Company | BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood Collection Tubes | 2026-03-13 | 256 |
Recalls for JKA devices
170 product recalls in 82 recall events; 26 initiated in the last five years and 23 still open. Most recent: 2025-12-19.
| Year | Recalls |
|---|---|
| 2017 | 5 |
| 2018 | 15 |
| 2019 | 27 |
| 2020 | 4 |
| 2021 | 7 |
| 2022 | 4 |
| 2023 | 4 |
| 2024 | 1 |
| 2025 | 14 |
Frequently asked questions
What is FDA product code JKA?
JKA is the FDA product code for tubes, vials, systems, serum separators, blood collection. It is a Class II device, regulated under 21 CFR 862.1675 and reviewed by the Clinical Chemistry panel.
What device class is JKA?
Class II, regulation 21 CFR 862.1675. Typical premarket route: 510(k).
How long does a 510(k) take for product code JKA?
Across 236 cleared submissions the average was 144 days from receipt to decision (median 92).
Which companies have the most JKA clearances?
Becton, Dickinson and Company (18); Bd Becton Dickinson Vacutainer Systems Preanalytic (13); Becton Dickinson Vacutainer Systems (11); Sherwood Medical Co. (9); Becton, Dickinson & CO (8).
Have JKA devices been recalled?
Yes: 170 product recalls across 82 recall events; the most recent began 2025-12-19.
Next steps
- Run an FDA pathway report with predicate devices for product code JKA
- Run a recall and safety report across every JKA manufacturer
- Watch product code JKA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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