FDA product code JQP: Calculator/Data Processing Module, For Clinical Use
JQP is the FDA product code for calculator/data processing module, for clinical use. It is a Class I device, regulated under 21 CFR 862.2100 and reviewed by the Clinical Chemistry panel. FDA has cleared 78 510(k) submissions under JQP, from 45 different applicants. The average 510(k) review took 64 days (median 38). FDA has posted 220 recalls for JQP devices, 15 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Calculator/Data Processing Module, For Clinical Use |
| Device class | Class I |
| Regulation | 21 CFR 862.2100 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JQP clearance
Top JQP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Miles Laboratories, Inc. | 8 | 1986-08-12 |
| Syva Co. | 7 | 1989-08-10 |
| Instrumentation Laboratory CO | 5 | 1982-03-11 |
| Biovation, Inc. | 4 | 1985-08-02 |
| Corning Medical & Scientific | 4 | 1983-03-25 |
40 more applicants have JQP clearances. See the full list in Caduvo.
Most recent JQP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K113007 | Bionime Corporation | BIONIME DIABETES MANAGEMENT SYSTEM VI.0 | 2012-02-27 | 143 |
| K983468 | Selfcare, Inc. | FASTTAKE ADAPTER, MODEL # P/N 020-072-01 | 1998-12-17 | 77 |
| K964460 | Shai Syg Motion and Innovations, Ltd. | THE ROBOLITE | 1997-01-24 | 78 |
| K953652 | Base Ten Systems, Inc. | PRENVAL I | 1995-09-15 | 39 |
| K934111 | Dynatech Laboratories, Inc. | MR7000 WITH TIME MANAGER SOFTWARE (TMS) | 1994-11-02 | 456 |
Recalls for JQP devices
220 product recalls in 188 recall events; 15 initiated in the last five years and 14 still open. Most recent: 2026-06-16.
| Year | Recalls |
|---|---|
| 2017 | 7 |
| 2018 | 16 |
| 2019 | 6 |
| 2020 | 8 |
| 2021 | 6 |
| 2022 | 3 |
| 2023 | 2 |
| 2024 | 5 |
| 2025 | 3 |
| 2026 | 2 |
Frequently asked questions
What is FDA product code JQP?
JQP is the FDA product code for calculator/data processing module, for clinical use. It is a Class I device, regulated under 21 CFR 862.2100 and reviewed by the Clinical Chemistry panel.
What device class is JQP?
Class I, regulation 21 CFR 862.2100. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JQP?
Across 78 cleared submissions the average was 64 days from receipt to decision (median 38).
Which companies have the most JQP clearances?
Miles Laboratories, Inc. (8); Syva Co. (7); Instrumentation Laboratory CO (5); Biovation, Inc. (4); Corning Medical & Scientific (4).
Have JQP devices been recalled?
Yes: 220 product recalls across 188 recall events; the most recent began 2026-06-16.
Next steps
- Run an FDA pathway report with predicate devices for product code JQP
- Run a recall and safety report across every JQP manufacturer
- Watch product code JQP 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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