510(k) Report

FDA product code · Anesthesiology

Percussor, Powered-Electric

BYIClass II21 CFR 868.5665510(k) required58 decisions since 19772 recalls

58 FDA decisions since 1977. 510(k) reviews decided 2021–2025 took a median of 157 days (half between 124 and 224). 2 recalls name this code, 0 of them Class I. The most-cited predicate is K024309, named by 4 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, anesthesiology panel

Twenty years of BYI 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 · BYI

1in 2025

2007: 12010: 12011: 12012: 12013: 32015: 12017: 12018: 12021: 22022: 12024: 32025: 12026 (partial year): 1
2007high 3 (2013) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BYI

157in 2024

2013: 225 days median2024: 157 days median
2007high 225 (2013) · low 157 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · BYI

1in 2017

2014: 12017: 1
2007high 1 (2014) · low 0 (2007)2026

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

Adverse event reports per year · BYI

38in 2025

2007: 82008: 52009: 82010: 72011: 172012: 82013: 62014: 102015: 42016: 42017: 42018: 92019: 62020: 42021: 152022: 162023: 92024: 192025: 38
2007high 38 (2025) · low 4 (2015)2025

MAUDE reports naming product code BYI, 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—08
20080—05
20090—08
20101—07
20111—017
20121—08
2013322506
20140—110
20151—04
20160—04
20171—14
20181—09
20190—06
20200—04
20212—015
20221—016
20230—09
20243157019
20251—038
20261—0—
FIG. 1 — BYI by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in BYI? 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 868.5665.