510(k) Report

510(k) · Cleared

Cleared

Glucose SR Liquid Stable Reagent Set

K853464510(k) TraditionalCleared Sep 4, 198516-day reviewClass II21 CFR 862.1345

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

Medical Analysis Systems, Inc. · CFR Hexokinase, Glucose

Cleared on Sep 4, 1985 after a 16-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 4, 1985
Review
16 days
Class
Class II
Product code
CFR
Recalls
None
Predicates
0

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

Descendants, by year cleared 1998: 1 descendant cleared1990200020102020
  1. This deviceK853464 Glucose SR Liquid Stable Reagent SetMedical Analysis Systems, Inc. · 1985
  2. Descendant · cites it directly · 0 of its ownK980883 N-Assay Glu-ULCrestat Diagnostics, Inc. · 1998

Most influential descendants

Showing 1 of 1 · See all
  • K980883N-Assay Glu-ULCrestat Diagnostics, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K853464Glucose SR Liquid Stable Reagent SetMedical Analysis Systems, Inc.1985—
+1K980883N-Assay Glu-ULCrestat Diagnostics, Inc.1998—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
FIG. 1 — Lineage of K853464, 1985–1998Source: 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 CFR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new CFR device

  1. #1 K253490 Glucose HK Gen.3; ONLINE DAT Methadone II…score 11.4 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin 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
K980883N-Assay Glu-ULCrestat Diagnostics, Inc.19980

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, K980883 (Crestat Diagnostics, Inc., 1998) has gone furthest, with 0 descendants of its own.

How does its category compare?

All CFR devices

CFR Hexokinase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CFR

1in 2025

2007: 12008: 52009: 32011: 32012: 42013: 12014: 12016: 22017: 12019: 12022: 12025: 12026 (partial year): 1
2007high 5 (2008) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CFR

115in 2012

2008: 182 days median2009: 101 days median2011: 316 days median2012: 115 days median
2007high 316 (2011) · low 101 (2009)2026

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

Recalls per year · CFR

1in 2016

2008: 72009: 12012: 12014: 12016: 1
2007high 7 (2008) · low 0 (2007)2026

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

Adverse event reports per year · CFR

16in 2025

2007: 12008: 22009: 72010: 112011: 432012: 492013: 362014: 22015: 32016: 12017: 132018: 82019: 102020: 42021: 52022: 32023: 292024: 152025: 16
2007high 49 (2012) · low 1 (2007)2025

MAUDE reports naming product code CFR, 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—01
2008518272
2009310117
20100—011
20113316043
20124115149
20131—036
20141—12
20150—03
20162—11
20171—013
20180—08
20191—010
20200—04
20210—05
20221—03
20230—029
20240—015
20251—016
20261—0—

More from Medical Analysis Systems, Inc.

107 FDA decisions under this applicant name. See the company

  • K042717Mas, Dade and Liquid Assayed Diabetes ControlMedical Analysis Systems, Inc. · 2004
  • K041194Abbott Architect Stat Troponin I Liquid Assayed Cardiac Marker Control Level L, M and HMedical Analysis Systems, Inc. · 2004
  • K040880Mas Cardioimmune TL Liquid Assayed Cardiac Marker Control, Levels 1,2 and 3Medical Analysis Systems, Inc. · 2004
  • K032826Mas Par TDMMedical Analysis Systems, Inc. · 2003
  • K032335Mas Cardioimmune Probnp, Mas Cardioimmune TLMedical Analysis Systems, Inc. · 2003

Recent decisions in CFR

The CFR category page

  • K253490Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutionsRoche Diagnostics · 2026
  • K252357Glucose2Abbott Ireland · 2025
  • K220134cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II…Roche Diagnostics · 2022
  • K191899Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutionsRoche Diagnostics · 20193 recalls
  • K170316Alinity C Glucose Reagent Kit, Alinity C SystemAbbott Laboratories · 20171 recall

https://510kreport.com/device/K853464 · printed Nov 4, 2026

Cite this page

510(k) Report. “K853464: Glucose SR Liquid Stable Reagent Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K853464

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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