510(k) Report

510(k) · Cleared

Cleared

Urinary/Cebrospinal Fluid Protein Calibrator

K934843510(k) TraditionalCleared Mar 11, 1994154-day reviewClass II21 CFR 862.1150

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

E.I. Dupont DE Nemours & Co., Inc. · JIT Calibrator, Secondary

Cleared on Mar 11, 1994 after a 154-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
Mar 11, 1994
Review
154 days
Class
Class II
Product code
JIT
Recalls
None
Predicates
0

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

Descendants, by year cleared 2006: 1 descendant cleared1990200020102020
  1. This deviceK934843 Urinary/Cebrospinal Fluid Protein CalibratorE.I. Dupont DE Nemours & Co., Inc. · 1994
  2. Descendant · cites it directly · 0 of its ownK061751 Dimension Vista System Ucfp Calibrator, Model KC260Dade Behring, Inc. · 2006

Most influential descendants

Showing 1 of 1 · See all
  • K061751Dimension Vista System Ucfp Calibrator, Model KC260Dade Behring, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K934843Urinary/Cebrospinal Fluid Protein CalibratorE.I. Dupont DE Nemours & Co., Inc.1994—
+1K061751Dimension Vista System Ucfp Calibrator, Model KC260Dade Behring, Inc.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
FIG. 1 — Lineage of K934843, 1994–2006Source: 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 JIT? 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
K061751Dimension Vista System Ucfp Calibrator, Model KC260Dade Behring, Inc.20060

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, K061751 (Dade Behring, Inc., 2006) has gone furthest, with 0 descendants of its own.

How does its category compare?

All JIT devices

JIT Calibrator, Secondary: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JIT

7in 2017

2007: 52008: 62009: 22010: 62011: 72012: 22013: 52014: 102015: 42016: 42017: 7
2007high 10 (2014) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JIT

28in 2017

2007: 78 days median2008: 46 days median2010: 65 days median2011: 48 days median2013: 140 days median2014: 33 days median2015: 30 days median2016: 33 days median2017: 28 days median
2007high 140 (2013) · low 28 (2017)2026

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

Recalls per year · JIT

1in 2023

2007: 12009: 22011: 32012: 32014: 22015: 12018: 52020: 22023: 12026 (partial year): 1
2007high 5 (2018) · low 0 (2008)2026

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

Adverse event reports per year · JIT

7in 2025

2010: 32011: 22012: 102013: 432014: 92015: 62016: 32017: 72018: 82019: 2152020: 122021: 32022: 42023: 62024: 172025: 7
2007high 215 (2019) · low 0 (2007)2025

MAUDE reports naming product code JIT, 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
200757810
200864600
20092—20
201066503
201174832
20122—310
20135140043
2014103329
201543016
201643303
201772807
20180—58
20190—0215
20200—212
20210—03
20220—04
20230—16
20240—017
20250—07
20260—1—

More from E.I. Dupont DE Nemours & Co., Inc.

253 FDA decisions under this applicant name. See the company

  • K951851Alliance Cytomegalovirus Immediate Early Antigen Direct Immunofluorescence AssayE.I. Dupont DE Nemours & Co., Inc. · 1996
  • K953724Cronex Radiation Therapy CassetteE.I. Dupont DE Nemours & Co., Inc. · 1995
  • K953725Cronex Radiation Therapy Verification CassetteE.I. Dupont DE Nemours & Co., Inc. · 1995
  • K951441Dupont Aca Digoxin (DGN a) MethodE.I. Dupont DE Nemours & Co., Inc. · 1995
  • K950137Urine Barbiturates Screen Flex (TM) Reagent CartridgeE.I. Dupont DE Nemours & Co., Inc. · 1995

Recent decisions in JIT

The JIT category page

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  • K163534Lumipulse G FSH-N CalibratorsFujirebio Diagnostics,Inc. · 2017

https://510kreport.com/device/K934843 · printed Nov 5, 2026

Cite this page

510(k) Report. “K934843: Urinary/Cebrospinal Fluid Protein Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K934843

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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