510(k) Report

FDA product code · Obstetrics and gynecology

Curette, Suction, Endometrial (And Accessories)

HHKClass II21 CFR 884.1175510(k) required42 decisions since 19763 recalls

42 FDA decisions since 1976. 510(k) reviews decided 2021–2025 took a median of 171 days (half between 145 and 198). 3 recalls name this code, 0 of them Class I. The most-cited predicate is K881456, named by 2 later devices.

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, obstetrics and gynecology panel

Twenty years of HHK 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 · HHK

1in 2025

2010: 12011: 12020: 22024: 12025: 1
2007high 2 (2020) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HHK

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

Recalls per year · HHK

1in 2022

2014: 22022: 1
2007high 2 (2014) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HHK

9in 2025

2008: 22013: 12015: 22016: 12017: 22018: 12019: 42021: 12022: 22023: 12024: 42025: 9
2007high 9 (2025) · low 0 (2007)2025

MAUDE reports naming product code HHK, 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—02
20090—00
20101—00
20111—00
20120—00
20130—01
20140—20
20150—02
20160—01
20170—02
20180—01
20190—04
20202—00
20210—01
20220—12
20230—01
20241—04
20251—09
20260—0—
FIG. 1 — HHK by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in HHK? 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 884.1175.