510(k) Report

FDA product code · General and plastic surgery

Implant, Dermal, For Aesthetic Use In The Hands

PKYClass IIIPMA required0 decisions since 20150 recalls

0 FDA decisions since 2015. No recall names this code.

For hand augmentation to correct volume loss in the dorsum of the hands.

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 PKY 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 · PKY

1in 2018

2015: 12018: 1
2007high 1 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PKY

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

Recalls per year · PKY

No recall names PKY since 2007.

Adverse event reports per year · PKY

1in 2022

2015: 12017: 12018: 12022: 1
2007high 1 (2015) · low 0 (2007)2025

MAUDE reports naming product code PKY, 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—00
20100—00
20110—00
20120—00
20130—00
20140—00
20151—01
20160—00
20170—01
20181—01
20190—00
20200—00
20210—00
20220—01
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — PKY by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PKY? 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