510(k) Report

FDA product code · Obstetrics and gynecology

Laparoscopic Contraceptive Tubal Occlusion Device

KNHClass III21 CFR 884.5380PMA required4 decisions since 19932 recalls

4 FDA decisions since 1993. 2 recalls name this code, 0 of them Class I.

Call for PMAs to be filed by 12/30/87 (52 FR 36883 (10/1/87))

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 KNH 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 · KNH

2in 2024

2007: 12008: 12009: 42010: 92011: 122012: 52014: 22015: 12016: 92017: 22019: 12020: 22021: 22022: 12023: 12024: 2
2007high 12 (2011) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KNH

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

Recalls per year · KNH

2in 2014

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

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

Adverse event reports per year · KNH

7in 2025

2007: 172008: 62009: 212010: 242011: 502012: 492013: 252014: 482015: 602016: 612017: 1052018: 1142019: 602020: 482021: 242022: 202023: 62024: 92025: 7
2007high 114 (2018) · low 6 (2008)2025

MAUDE reports naming product code KNH, 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
20071—017
20081—06
20094—021
20109—024
201112—050
20125—049
20130—025
20142—248
20151—060
20169—061
20172—0105
20180—0114
20191—060
20202—048
20212—024
20221—020
20231—06
20242—09
20250—07
20260—0—
FIG. 1 — KNH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in KNH? 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 884.5380.