FDA product code JRM: Freezer
JRM is the FDA product code for freezer. It is a Class I device, regulated under 21 CFR 862.2050 and reviewed by the Clinical Chemistry panel. FDA has cleared 7 510(k) submissions under JRM, from 4 different applicants. The average 510(k) review took 78 days (median 68). FDA has posted 1 recall for JRM devices.
Classification
| Field | Value |
|---|---|
| Device name | Freezer |
| 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 JRM clearance
Top JRM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Mnlase, Inc. | 4 | 1992-06-09 |
| Taylor Corp. | 1 | 1991-09-25 |
| Saniserv, Inc. | 1 | 1989-11-03 |
| Sherwood Medical Industries | 1 | 1979-04-03 |
Most recent JRM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K921569 | Mnlase, Inc. | ORS-200 | 1992-06-09 | 68 |
| K921570 | Mnlase, Inc. | ORS-300 | 1992-06-09 | 68 |
| K921568 | Mnlase, Inc. | ORS-100 | 1992-06-09 | 68 |
| K915427 | Mnlase, Inc. | ORS-1000 | 1992-01-07 | 36 |
| K913777 | Taylor Corp. | SELF-CONTAINED SURGICAL SLUSH FREEZER | 1991-09-25 | 42 |
Recalls for JRM devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-03-20.
Frequently asked questions
What is FDA product code JRM?
JRM is the FDA product code for freezer. It is a Class I device, regulated under 21 CFR 862.2050 and reviewed by the Clinical Chemistry panel.
What device class is JRM?
Class I, regulation 21 CFR 862.2050. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JRM?
Across 7 cleared submissions the average was 78 days from receipt to decision (median 68).
Which companies have the most JRM clearances?
Mnlase, Inc. (4); Taylor Corp. (1); Saniserv, Inc. (1); Sherwood Medical Industries (1).
Have JRM devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2014-03-20.
Next steps
- Run an FDA pathway report with predicate devices for product code JRM
- Run a recall and safety report across every JRM manufacturer
- Watch product code JRM 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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