510(k) Report

FDA product code · Clinical chemistry

Test, Natriuretic Peptide

NBCClass II21 CFR 862.1117510(k) required47 decisions since 20009 recalls

47 FDA decisions since 2000. 510(k) reviews decided 2021–2025 took a median of 266 days (half between 245 and 452). 9 recalls name this code, 0 of them Class I. The most-cited predicate is K022516, named by 9 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, clinical chemistry panel

Twenty years of NBC 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 · NBC

1in 2025

2007: 22008: 72010: 12020: 12021: 22022: 12023: 22024: 12025: 12026 (partial year): 4
2007high 7 (2008) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NBC

126in 2008

2008: 126 days median2026 (partial year): 94 days median
2007high 126 (2008)2026

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

Recalls per year · NBC

1in 2020

2010: 12012: 22014: 12015: 12018: 12020: 1
2007high 2 (2012) · low 0 (2007)2026

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

Adverse event reports per year · NBC

17in 2025

2007: 172008: 152009: 352010: 612011: 532012: 232013: 132014: 702015: 432016: 312017: 92018: 72019: 92020: 62022: 42023: 262024: 142025: 17
2007high 70 (2014) · low 0 (2021)2025

MAUDE reports naming product code NBC, 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—017
20087126015
20090—035
20101—161
20110—053
20120—223
20130—013
20140—170
20150—143
20160—031
20170—09
20180—17
20190—09
20201—16
20212—00
20221—04
20232—026
20241—014
20251—017
20264940—
FIG. 1 — NBC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NBC? 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 862.1117.