510(k) Report

510(k) · Cleared

Cleared

Array (R) 360

K922273510(k) TraditionalCleared Aug 19, 199297-day reviewClass I21 CFR 862.2700

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

Beckman Instruments, Inc. · JQX Nephelometer, For Clinical Use

Cleared on Aug 19, 1992 after a 97-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 14 later devices descend from it.

Decided
Aug 19, 1992
Review
97 days
Class
Class I
Product code
JQX
Recalls
None
Predicates
0

14 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 2000: 4 descendants cleared1996: 1 descendant cleared1999: 3 descendants cleared2005: 1 descendant cleared2015: 2 descendants cleared2008: 2 descendants cleared2006: 1 descendant cleared1990200020102020
  1. This deviceK922273 Array (R) 360Beckman Instruments, Inc. · 1992
  2. Descendant · cites it directly · 6 of its ownK990551 Igg Flex Reagent CartridgeDade Behring, Inc. · 1999
  3. Descendant · 2 generations on · 5 of its ownK051087 Dimension Vista Integrated SystemDade Behring, Inc. · 2005 · Recalled
  4. Descendant · 3 generations on · 1 of its ownK073561 Dimension Vista System Immunoglobulin G Flex Reagent Cartridge…Dade Behring, Inc. · 2008
  5. Descendant · 3 generations on · 1 of its ownK061838 Dimension Vista Chemistry 1 Calibrator, Model KC110Dade Behring, Inc. · 2006 · Recalled
  6. Descendant · 3 generations on · 0 of its ownK143720 Dimension Vista MMB AssaySiemens Healthcare Diagnostics · 2015 · Recalled

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

1996: 11999: 32000: 42005: 12006: 12008: 22015: 2
1996high 4 (2000) · low 0 (1997)2026

Most influential descendants

Showing 5 of 14 · See all
  • K990551Igg Flex Reagent CartridgeDade Behring, Inc. · 1999 · cites it directly6descendants
  • K051087Dimension Vista Integrated SystemDade Behring, Inc. · 2005 · 2 generations on5descendants
  • K073561Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension Vista System…Dade Behring, Inc. · 2008 · 3 generations on1descendant
  • K061838Dimension Vista Chemistry 1 Calibrator, Model KC110Dade Behring, Inc. · 2006 · 3 generations on1descendant
  • K143720Dimension Vista MMB AssaySiemens Healthcare Diagnostics · 2015 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K922273Array (R) 360Beckman Instruments, Inc.1992—
+1K990551Igg Flex Reagent CartridgeDade Behring, Inc.1999—
+2K051087Dimension Vista Integrated SystemDade Behring, Inc.200532
+3K073561Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension…Dade Behring, Inc.2008—
+3K061838Dimension Vista Chemistry 1 Calibrator, Model KC110Dade Behring, Inc.20063
+3K143720Dimension Vista MMB AssaySiemens Healthcare Diagnostics20155

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199930
200040
200510
200610
200820
201520
FIG. 1 — Lineage of K922273, 1992–2015Source: 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 JQX? 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? (14)

See all 14

8 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K990551Igg Flex Reagent CartridgeDade Behring, Inc.19996
K994293Dimension C4 Flex Reagent CartridgeDade Behring, Inc.20000
K994296Dimension C3 Flex Reagent CartridgeDade Behring, Inc.20000
K994294Dimension TRNF Flex Reagent CartridgeDade Behring, Inc.20000
K994035Immunodip Urinary Albumin Screen, Model 790-01, 790-15Diagnostic Chemicals, Ltd.20000
K990552Immunoglobulin a Test SystemDade Behring, Inc.19990
K990553Igm Flex Reagent CartridgeDade Behring, Inc.19990
K962294Immage Immunochemistry SystemBeckman Instruments, Inc.19960

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, K990551 (Dade Behring, Inc., 1999) has gone furthest, with 6 descendants of its own.

How does its category compare?

All JQX devices

JQX Nephelometer, For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JQX

FDA has decided no JQX device since 2007.

Median 510(k) review, days · JQX

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

Recalls per year · JQX

1in 2017

2010: 12017: 1
2007high 1 (2010) · low 0 (2007)2026

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

Adverse event reports per year · JQX

18in 2025

2009: 22010: 142011: 372012: 162013: 12014: 12018: 12019: 12020: 102021: 122022: 242023: 272024: 782025: 18
2007high 78 (2024) · low 0 (2007)2025

MAUDE reports naming product code JQX, 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
20070—00
20080—00
20090—02
20100—114
20110—037
20120—016
20130—01
20140—01
20150—00
20160—00
20170—10
20180—01
20190—01
20200—010
20210—012
20220—024
20230—027
20240—078
20250—018
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 JQX

The JQX category page

  • K962294Immage Immunochemistry SystemBeckman Instruments, Inc. · 19962 recalls
  • K885263QMS (TM) - TheophyllineSeradyn, Inc. · 1989
  • K851253TDX Analyzer W/Nephelometry CarouselAbbott Laboratories · 1985
  • K851234A-Just Turbidity MeterAbbott Laboratories · 1985
  • K801362Albumin Nephelometric AssayJ.T. Baker Chemical Co. · 1980

https://510kreport.com/device/K922273 · printed Nov 6, 2026

Cite this page

510(k) Report. “K922273: Array (R) 360.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K922273

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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