FDA product code JJH: Clinical Sample Concentrator
JJH is the FDA product code for clinical sample concentrator. It is a Class I device, regulated under 21 CFR 862.2310 and reviewed by the Clinical Chemistry panel. FDA has cleared 15 510(k) submissions under JJH, from 8 different applicants. The average 510(k) review took 120 days (median 77). FDA has posted 31 recalls for JJH devices, 11 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Clinical Sample Concentrator |
| Device class | Class I |
| Regulation | 21 CFR 862.2310 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JJH clearance
Top JJH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Amicon, Inc. | 6 | 1993-08-05 |
| Vivascience, Inc. | 3 | 1996-03-19 |
| Clinical Micro Sensors, Inc. | 1 | 2012-09-10 |
| Millipore Corp. | 1 | 1994-05-27 |
| Intersep , Ltd. | 1 | 1994-04-26 |
3 more applicants have JJH clearances. See the full list in Caduvo.
Most recent JJH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K113731 | Clinical Micro Sensors, Inc. | ESENSOR RESPIRATORY VIRAL PANEL | 2012-09-10 | 266 |
| K960298 | Vivascience, Inc. | VIVASPIN 4 10,000 MW | 1996-03-19 | 57 |
| K943965 | Vivascience, Inc. | VIVAPORE 10 | 1995-04-11 | 257 |
| K943966 | Vivascience, Inc. | VIVAPORE 2 | 1995-04-11 | 257 |
| K941326 | Millipore Corp. | ULTRAFREE-CL | 1994-05-27 | 70 |
Recalls for JJH devices
31 product recalls in 23 recall events; 11 initiated in the last five years and 12 still open. Most recent: 2024-06-03.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 4 |
| 2019 | 5 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 7 |
| 2024 | 2 |
Frequently asked questions
What is FDA product code JJH?
JJH is the FDA product code for clinical sample concentrator. It is a Class I device, regulated under 21 CFR 862.2310 and reviewed by the Clinical Chemistry panel.
What device class is JJH?
Class I, regulation 21 CFR 862.2310. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JJH?
Across 15 cleared submissions the average was 120 days from receipt to decision (median 77).
Which companies have the most JJH clearances?
Amicon, Inc. (6); Vivascience, Inc. (3); Clinical Micro Sensors, Inc. (1); Millipore Corp. (1); Intersep , Ltd. (1).
Have JJH devices been recalled?
Yes: 31 product recalls across 23 recall events; the most recent began 2024-06-03.
Next steps
- Run an FDA pathway report with predicate devices for product code JJH
- Run a recall and safety report across every JJH manufacturer
- Watch product code JJH 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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