FDA product code JIN: Nitroprusside, Ketones (Urinary, Non-Quant.)
JIN is the FDA product code for nitroprusside, ketones (urinary, non-quant.). It is a Class I device, regulated under 21 CFR 862.1435 and reviewed by the Clinical Chemistry panel. FDA has cleared 24 510(k) submissions under JIN, from 19 different applicants. The average 510(k) review took 135 days (median 117). FDA has posted 14 recalls for JIN devices, 6 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Nitroprusside, Ketones (Urinary, Non-Quant.) |
| Device class | Class I |
| Regulation | 21 CFR 862.1435 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
510(k) clearances per year for JIN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 128 |
| 2018 | 3 | 234 |
| 2020 | 2 | 160 |
Compare with all 510(k) review times · Search every JIN clearance
Top JIN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ihara Medics U.S., Inc. | 4 | 1991-07-01 |
| I-Sens, Inc. | 2 | 2020-09-09 |
| Polymer Technology Intl. | 2 | 1996-06-14 |
| Vivachek Biotech (Hangzhou) Co., Ltd. | 1 | 2020-06-05 |
| Apex BioTechnology Corp. | 1 | 2018-12-18 |
14 more applicants have JIN clearances. See the full list in Caduvo.
Most recent JIN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K201551 | I-Sens, Inc. | KetoSens BT Blood B-Ketone Monitoring System | 2020-09-09 | 92 |
| K192957 | Vivachek Biotech (Hangzhou) Co., Ltd. | VivaChek Blood Glucose and B-Ketone Monitoring System | 2020-06-05 | 228 |
| K182593 | Apex BioTechnology Corp. | KET-1 Blood Ketone Monitoring System | 2018-12-18 | 89 |
| K173345 | Taidoc Technology Corporation | TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System | 2018-05-04 | 192 |
| K170463 | I-Sens, Inc. | KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System | 2018-04-13 | 422 |
Recalls for JIN devices
14 product recalls in 9 recall events; 6 initiated in the last five years and 6 still open. Most recent: 2026-04-02.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 6 |
| 2022 | 1 |
| 2023 | 3 |
| 2025 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code JIN?
JIN is the FDA product code for nitroprusside, ketones (urinary, non-quant.). It is a Class I device, regulated under 21 CFR 862.1435 and reviewed by the Clinical Chemistry panel.
What device class is JIN?
Class I, regulation 21 CFR 862.1435. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JIN?
Across 24 cleared submissions the average was 135 days from receipt to decision (median 117).
Which companies have the most JIN clearances?
Ihara Medics U.S., Inc. (4); I-Sens, Inc. (2); Polymer Technology Intl. (2); Vivachek Biotech (Hangzhou) Co., Ltd. (1); Apex BioTechnology Corp. (1).
Have JIN devices been recalled?
Yes: 14 product recalls across 9 recall events; the most recent began 2026-04-02.
Next steps
- Run an FDA pathway report with predicate devices for product code JIN
- Run a recall and safety report across every JIN manufacturer
- Watch product code JIN 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.
All Clinical Chemistry product codes · FDA product code lookup · 510(k) database search · 510(k) review times