510(k) Report

FDA product code · Cardiovascular

Stethoscope, Electronic

DQDClass II21 CFR 870.1875510(k) required157 decisions since 19770 recalls

157 FDA decisions since 1977. 510(k) reviews decided 2021–2025 took a median of 136 days (half between 104 and 201). No recall names this code. The most-cited predicate is K083903, named by 17 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, cardiovascular panel

Twenty years of DQD 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 · DQD

3in 2025

2007: 22008: 12009: 62010: 12011: 42012: 22013: 52015: 22016: 32017: 42018: 42019: 42020: 62021: 42022: 82023: 102024: 42025: 32026 (partial year): 6
2007high 10 (2023) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQD

89in 2025

2009: 161 days median2011: 107 days median2013: 70 days median2016: 250 days median2017: 109 days median2018: 131 days median2019: 262 days median2020: 104 days median2021: 137 days median2022: 203 days median2023: 132 days median2024: 153 days median2025: 89 days median2026 (partial year): 236 days median
2007high 262 (2019) · low 70 (2013)2026

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

Recalls per year · DQD

No recall names DQD since 2007.

Adverse event reports per year · DQD

1in 2024

2011: 12013: 12024: 1
2007high 1 (2011) · low 0 (2007)2025

MAUDE reports naming product code DQD, 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—00
20081—00
2009616100
20101—00
2011410701
20122—00
201357001
20140—00
20152—00
2016325000
2017410900
2018413100
2019426200
2020610400
2021413700
2022820300
20231013200
2024415301
202538900
202662360—
FIG. 1 — DQD by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in DQD? 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 870.1875.