510(k) Report

510(k) · Cleared

Cleared

Beckman Immunoglobulin G (Igg) Reagent, Urine Application, Urine Protein Calibrator, Control

K951635510(k) TraditionalCleared May 15, 199538-day reviewClass II21 CFR 866.5510

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

Beckman Instruments, Inc. · DEW Igg, Antigen, Antiserum, Control

Cleared on May 15, 1995 after a 38-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.

Decided
May 15, 1995
Review
38 days
Class
Class II
Product code
DEW
Recalls
None
Predicates
0

6 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 1997: 2 descendants cleared2008: 1 descendant cleared2009: 1 descendant cleared2000: 1 descendant cleared2023: 1 descendant cleared1995200020052010201520202025
  1. This deviceK951635 Beckman Immunoglobulin G (Igg) Reagent, Urine Application, Urine…Beckman Instruments, Inc. · 1995
  2. Descendant · cites it directly · 2 of its ownK963974 Image-Immunochemistry System Urine ImmunoglobulinBeckman Instruments, Inc. · 1997
  3. Descendant · 2 generations on · 1 of its ownK083445 N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T…Siemens Healthcare Diagnostics · 2009 · Recalled
  4. Descendant · cites it directly · 1 of its ownK973928 Beckman Urine Protein Calibrator (Ucal)Beckman Instruments, Inc. · 1997
  5. Descendant · 3 generations on · 0 of its ownK233663 N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)Siemens Healthcare Diagnostics Products GmbH · 2023
  6. Descendant · cites it directly · 0 of its ownK081161 Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista…Dade Behring, Inc. · 2008

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

1997: 22000: 12008: 12009: 12023: 1
1997high 2 (1997) · low 0 (1998)2026

Most influential descendants

Showing 5 of 6 · See all
  • K963974Image-Immunochemistry System Urine ImmunoglobulinBeckman Instruments, Inc. · 1997 · cites it directly2descendants
  • K083445N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T Protein Control LCSiemens Healthcare Diagnostics · 2009 · 2 generations on1descendant
  • K973928Beckman Urine Protein Calibrator (Ucal)Beckman Instruments, Inc. · 1997 · cites it directly1descendant
  • K233663N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)Siemens Healthcare Diagnostics Products GmbH · 2023 · 3 generations on0descendants
  • K081161Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System Protein 1…Dade Behring, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K951635Beckman Immunoglobulin G (Igg) Reagent, Urine Application, Urine Protein…Beckman Instruments, Inc.1995—
+1K963974Image-Immunochemistry System Urine ImmunoglobulinBeckman Instruments, Inc.1997—
+2K083445N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T Protein Control…Siemens Healthcare Diagnostics20092
+1K973928Beckman Urine Protein Calibrator (Ucal)Beckman Instruments, Inc.1997—
+3K233663N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)Siemens Healthcare Diagnostics Products GmbH2023—
+1K081161Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System…Dade Behring, Inc.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199720
200010
200810
200910
202310
FIG. 1 — Lineage of K951635, 1995–2023Source: 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 DEW? 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? (6)

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

NumberDeviceApplicantDecidedDescendants
K963974Image-Immunochemistry System Urine ImmunoglobulinBeckman Instruments, Inc.19972
K973928Beckman Urine Protein Calibrator (Ucal)Beckman Instruments, Inc.19971
K081161Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System Protein 1…Dade Behring, Inc.20080

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, K963974 (Beckman Instruments, Inc., 1997) has gone furthest, with 2 descendants of its own.

How does its category compare?

All DEW devices

DEW Igg, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DEW

FDA has decided no DEW device since 2007.

Median 510(k) review, days · DEW

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

Recalls per year · DEW

1in 2024

2010: 12024: 1
2007high 1 (2010) · low 0 (2007)2026

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

Adverse event reports per year · DEW

4in 2024

2009: 42010: 22011: 162015: 22016: 42017: 62018: 12019: 92020: 192023: 12024: 4
2007high 19 (2020) · low 0 (2007)2025

MAUDE reports naming product code DEW, 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—04
20100—12
20110—016
20120—00
20130—00
20140—00
20150—02
20160—04
20170—06
20180—01
20190—09
20200—019
20210—00
20220—00
20230—01
20240—14
20250—00
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 DEW

The DEW category page

  • K050113Tina-Quant Igg Gen.2Roche Diagnostics Corp. · 2005
  • K040434Roche Diagnostics Tina-Quant Igg Gen.2Roche Diagnostics Corp. · 2004
  • K010617Spife Ife Calibrator and Control KitHelena Laboratories · 2001
  • K993928Wako-Igg II-HA, Immunoglobulin Calibrator Set, Immunolobulin StandardWako Chemicals USA, Inc. · 2000
  • K993281K-Assay IggKamiya Biomedical Co. · 1999

https://510kreport.com/device/K951635 · printed Nov 4, 2026

Cite this page

510(k) Report. “K951635: Beckman Immunoglobulin G (Igg) Reagent, Urine Application, Urine Protein Calibrator, Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K951635

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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