FDA product code PPM: General Purpose Reagent
PPM is the FDA product code for general purpose reagent. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel. FDA has cleared 16 510(k) submissions under PPM, from 12 different applicants. The average 510(k) review took 36 days (median 28). FDA has posted 30 recalls for PPM devices, 14 initiated in the last five years.
Definition
A general purpose reagent is a chemical reagent that has general laboratory application, that is used to collect, prepare, and examine specimens from the human body for diagnostic purposes, and that is not labeled or otherwise intended for a specific diagnostic application. It may be either an individual substance, or multiple substances reformulated, which, when combined with or used in conjunction with an appropriate analyte specific reagent (ASR) and other general purpose reagents, is part of a diagnostic test procedure or system constituting a finished in vitro diagnostic (IVD) test.
Classification
| Field | Value |
|---|---|
| Device name | General Purpose Reagent |
| Device class | Class I |
| Regulation | 21 CFR 864.4010 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every PPM clearance
Top PPM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Richard-Allan Medical Ind., Inc. | 3 | 1986-06-03 |
| E K Ind., Inc. | 2 | 1984-09-12 |
| Omega Medical Diagnostics | 2 | 1983-07-28 |
| Remel Co. | 1 | 1987-04-29 |
| Reagent Laboratory, Inc. | 1 | 1986-10-02 |
7 more applicants have PPM clearances. See the full list in Caduvo.
Most recent PPM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K871533 | Remel Co. | TOMTEC GRAM STAINER DECOLORIZER | 1987-04-29 | 9 |
| K863550 | Reagent Laboratory, Inc. | POTASSIUM HYDROXIDE 10% W/V | 1986-10-02 | 20 |
| K861890 | Richard-Allan Medical Ind., Inc. | 100%, 95%, 80% & 70% DEHYDRANT CUSTOM BLEND NO. 2 | 1986-06-03 | 18 |
| K850916 | Surgipath Medical Industries, Inc. | SPRAYFIX | 1985-03-25 | 20 |
| K850845 | Micro Media Laboratories | 0.85% SALINE | 1985-03-20 | 19 |
Recalls for PPM devices
30 product recalls in 23 recall events; 14 initiated in the last five years and 13 still open. Most recent: 2026-03-26.
| Year | Recalls |
|---|---|
| 2017 | 5 |
| 2018 | 7 |
| 2020 | 2 |
| 2021 | 1 |
| 2022 | 3 |
| 2023 | 1 |
| 2024 | 3 |
| 2025 | 5 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code PPM?
PPM is the FDA product code for general purpose reagent. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel.
What device class is PPM?
Class I, regulation 21 CFR 864.4010. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code PPM?
Across 16 cleared submissions the average was 36 days from receipt to decision (median 28).
Which companies have the most PPM clearances?
Richard-Allan Medical Ind., Inc. (3); E K Ind., Inc. (2); Omega Medical Diagnostics (2); Remel Co. (1); Reagent Laboratory, Inc. (1).
Have PPM devices been recalled?
Yes: 30 product recalls across 23 recall events; the most recent began 2026-03-26.
Next steps
- Run an FDA pathway report with predicate devices for product code PPM
- Run a recall and safety report across every PPM manufacturer
- Watch product code PPM 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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