FDA product code · Pathology

General Purpose Reagent

Name: FDA decisions, review times, recalls and adverse event reports for product code PPM
Creator: 510(k) Report

PPMClass I21 CFR 864.4010510(k) exempt16 decisions since 198115 recalls

FDA lists PPM as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 864.9 applies, such as a new intended use or a different fundamental technology. 16 FDA decisions since 1981. 15 recalls name this code, 5 of them Class I.

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…

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, pathology panel

Twenty years of PPM at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · PPM

FDA has decided no PPM device since 2007.

Median 510(k) review, days · PPM

Too few PPM 510(k)s in any year since 2007 to give a median.

Recalls per year · PPM

3in 2025

2007high 4 (2017) · low 0 (2007)2026

Class I (5 since 2007) Class II/III not classified

Adverse event reports per year · PPM

230in 2025

2007high 230 (2025) · low 0 (2007)2025

MAUDE reports naming product code PPM, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	0	0
2009	—	0	0
2010	—	0	0
2011	—	0	0
2012	—	0	0
2013	—	0	0
2014	—	0	0
2015	—	0	1
2016	—	2 (2)	1
2017	—	4 (3)	10
2018	—	2	4
2019	—	0	5
2020	—	0	1
2021	—	1	12
2022	—	1	31
2023	—	0	8
2024	—	1	6
2025	—	3	230
2026	—	1	—

FIG. 1 — PPM by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PPM? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Related product codes

Other codes under 21 CFR 864.4010.

KDX Solution, Decalcifier, Acid Containing IEZ Celloidin IGN Fluid, Bouin'S LEA Preservative, Cytological IAT Syrup, Gum, Apathy'S IFZ Gelatin For Specimen Adhesion IEX Gelatin LDX Fixative, Metallic Containing IAY Colchicine IFF Solution, Decalcifier, Electrolytic HZI Acid, Osmic KDY Agent, Chelating For Decalcification

General Purpose Reagent

What has FDA decided in PPM lately?

What has been recalled in PPM lately?

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