510(k) Report

FDA product code · General and plastic surgery

Apparatus, Pneumoperitoneum, Automatic

FDPClass II21 CFR 876.1500510(k) required1 decision since 19910 recalls

1 FDA decision since 1991. No recall names this code.

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, general and plastic surgery panel

Twenty years of FDP 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 · FDP

FDA has decided no FDP device since 2007.

Median 510(k) review, days · FDP

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

Recalls per year · FDP

No recall names FDP since 2007.

Adverse event reports per year · FDP

16in 2025

2009: 232010: 142011: 22012: 22013: 12014: 12015: 112016: 22017: 22019: 22020: 32021: 12022: 72023: 62024: 222025: 16
2007high 23 (2009) · low 0 (2007)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—023
20100—014
20110—02
20120—02
20130—01
20140—01
20150—011
20160—02
20170—02
20180—00
20190—02
20200—03
20210—01
20220—07
20230—06
20240—022
20250—016
20260—0—
FIG. 1 — FDP by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in FDP? 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 876.1500.