510(k) Report

510(k) · Cleared

Cleared

Dri-Stat Enzymatic Bilirubin Test Kit

K843174510(k) TraditionalCleared Sep 14, 198432-day reviewClass II21 CFR 862.1110

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Beckman Instruments, Inc. · JFM Enzymatic Method, Bilirubin

Cleared on Sep 14, 1984 after a 32-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Sep 14, 1984
Review
32 days
Class
Class II
Product code
JFM
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared19801990200020102020
  1. This deviceK843174 Dri-Stat Enzymatic Bilirubin Test KitBeckman Instruments, Inc. · 1984
  2. Descendant · cites it directly · 0 of its ownK053090 Dri-Stat Enzymatic Bilirubin Reagent, Synchron Systems Bilirubin…Beckman Coulter, Inc. · 2005

Most influential descendants

Showing 1 of 1 · See all
  • K053090Dri-Stat Enzymatic Bilirubin Reagent, Synchron Systems Bilirubin CalibratorBeckman Coulter, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K843174Dri-Stat Enzymatic Bilirubin Test KitBeckman Instruments, Inc.1984—
+1K053090Dri-Stat Enzymatic Bilirubin Reagent, Synchron Systems Bilirubin CalibratorBeckman Coulter, Inc.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
FIG. 1 — Lineage of K843174, 1984–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JFM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K053090Dri-Stat Enzymatic Bilirubin Reagent, Synchron Systems Bilirubin CalibratorBeckman Coulter, Inc.20050

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K053090 (Beckman Coulter, Inc., 2005) has gone furthest, with 0 descendants of its own.

How does its category compare?

All JFM devices

JFM Enzymatic Method, Bilirubin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JFM

1in 2017

2007: 12016: 22017: 1
2007high 2 (2016) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JFM

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

Recalls per year · JFM

1in 2023

2023: 1
2007high 1 (2023) · low 0 (2007)2026

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

Adverse event reports per year · JFM

1in 2025

2007: 82008: 22010: 72011: 62012: 12015: 22021: 12023: 12024: 12025: 1
2007high 8 (2007) · low 0 (2009)2025

MAUDE reports naming product code JFM, 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—02
20090—00
20100—07
20110—06
20120—01
20130—00
20140—00
20150—02
20162—00
20171—00
20180—00
20190—00
20200—00
20210—01
20220—00
20230—11
20240—01
20250—01
20260—0—

More from Beckman Instruments, Inc.

281 FDA decisions under this applicant name. See the company

  • K973448Access Toxoplasma Igm Reagents on the Access Immunoassay Analyzer, Models 34460, 34465, 34469Beckman Instruments, Inc. · 1998
  • K982250Access Free T4 Reagents on the Access Immunoassay AnalyzerBeckman Instruments, Inc. · 19984 recalls
  • K981403Immage Immunochemistry System Valproic Acid (Vpa) ReagentBeckman Instruments, Inc. · 1998
  • K981354Access Afp Reagents on the Access Immunoassay Analyzer Model Number 33211Beckman Instruments, Inc. · 19981 recall
  • K980173Access Total BHCG Reagents on the Access Immunoassay Analyzer; 33500, 33505Beckman Instruments, Inc. · 19981 recall

Recent decisions in JFM

The JFM category page

  • K170065ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)Siemens Healthcare Diagnostics, Inc. · 20172 recalls
  • K152343Direct BilirubinRandox Laboratories Limited · 2016
  • K152344Total BilirubinRandox Laboratories Limited · 20161 recall
  • K063845Advia Chemistry Total Bilirubin_2Bayer Healthcare, LLC · 2007
  • K053131Wako Total Bilirubin V, Models 410-22701, 998-23291, 416-22801, 990-23191Wako Chemicals USA, Inc. · 20051 recall

https://510kreport.com/device/K843174 · printed Nov 6, 2026

Cite this page

510(k) Report. “K843174: Dri-Stat Enzymatic Bilirubin Test Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K843174

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026