510(k) Report

FDA product code · Anesthesiology

Unit, Liquid-Oxygen, Portable

BYJClass II21 CFR 868.5655510(k) required55 decisions since 19766 recalls

55 FDA decisions since 1976. 6 recalls name this code, 4 of them Class I. The most-cited predicate is K993220, 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 BYJ 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 · BYJ

1in 2013

2007: 22008: 32010: 12011: 12012: 12013: 1
2007high 3 (2008) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BYJ

164in 2008

2008: 164 days median
2007high 164 (2008)2026

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

Recalls per year · BYJ

4in 2022

2007: 12022: 4, 4 Class I
2007high 4 (2022) · low 0 (2008)2026

Class I (4 since 2007) Class II/III not classified

Adverse event reports per year · BYJ

1in 2025

2007: 242008: 332009: 122010: 242011: 152012: 112013: 222014: 252015: 342016: 192017: 182018: 212019: 242020: 392021: 72022: 42023: 102024: 102025: 1
2007high 39 (2020) · low 1 (2025)2025

MAUDE reports naming product code BYJ, 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
20072—124
20083164033
20090—012
20101—024
20111—015
20121—011
20131—022
20140—025
20150—034
20160—019
20170—018
20180—021
20190—024
20200—039
20210—07
20220—4 (4)4
20230—010
20240—010
20250—01
20260—0—
FIG. 1 — BYJ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in BYJ? 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 868.5655.