FDA product code JRL: Unit, Filter, Membrane
JRL is the FDA product code for unit, filter, membrane. It is a Class I device, regulated under 21 CFR 862.2050 and reviewed by the Clinical Chemistry panel. FDA has cleared 9 510(k) submissions under JRL, from 5 different applicants. The average 510(k) review took 53 days (median 27).
Classification
| Field | Value |
|---|---|
| Device name | Unit, Filter, Membrane |
| Device class | Class I |
| Regulation | 21 CFR 862.2050 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every JRL clearance
Top JRL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Gelman Sciences, Inc. | 3 | 1982-08-05 |
| Millipore Corp. | 3 | 1980-08-20 |
| Amicon, Inc. | 1 | 1982-03-15 |
| Syva Co. | 1 | 1982-02-23 |
| Instrumentation Laboratory CO | 1 | 1982-01-26 |
Most recent JRL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K822121 | Gelman Sciences, Inc. | ACRO PACK | 1982-08-05 | 17 |
| K820455 | Amicon, Inc. | CENTRIFREE MICROPARTITION SYSTEM | 1982-03-15 | 24 |
| K820224 | Syva Co. | EMIT FREELEVEL SYSTEM I | 1982-02-23 | 27 |
| K812750 | Instrumentation Laboratory CO | IL 703, STAT SEPARATOR | 1982-01-26 | 119 |
| K813159 | Gelman Sciences, Inc. | VACUSHIELD TM | 1981-12-08 | 22 |
Recalls for JRL devices
openFDA lists no recalls for product code JRL.
Frequently asked questions
What is FDA product code JRL?
JRL is the FDA product code for unit, filter, membrane. It is a Class I device, regulated under 21 CFR 862.2050 and reviewed by the Clinical Chemistry panel.
What device class is JRL?
Class I, regulation 21 CFR 862.2050. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JRL?
Across 9 cleared submissions the average was 53 days from receipt to decision (median 27).
Which companies have the most JRL clearances?
Gelman Sciences, Inc. (3); Millipore Corp. (3); Amicon, Inc. (1); Syva Co. (1); Instrumentation Laboratory CO (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JRL
- Run a recall and safety report across every JRL manufacturer
- Watch product code JRL 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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