510(k) Report

510(k) · Cleared

Cleared

Diacare Monitoring System

K882001510(k) TraditionalCleared Oct 18, 1988159-day reviewClass II21 CFR 868.1890

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

Healthware Corp. · NDC Calculator, Drug Dose

Cleared on Oct 18, 1988 after a 159-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
Oct 18, 1988
Review
159 days
Class
Class II
Product code
NDC
Recalls
None
Predicates
0

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

Descendants, by year cleared 2005: 1 descendant cleared1990200020102020
  1. This deviceK882001 Diacare Monitoring SystemHealthware Corp. · 1988
  2. Descendant · cites it directly · 0 of its ownK050821 Coagcare Anticoagulation Management SystemZycare · 2005

Most influential descendants

Showing 1 of 1 · See all
  • K050821Coagcare Anticoagulation Management SystemZycare · 2005 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K882001Diacare Monitoring SystemHealthware Corp.1988—
+1K050821Coagcare Anticoagulation Management SystemZycare2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
FIG. 1 — Lineage of K882001, 1988–2005Source: 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 NDC? 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 NDC device

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  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
K050821Coagcare Anticoagulation Management SystemZycare20050

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, K050821 (Zycare, 2005) has gone furthest, with 0 descendants of its own.

How does its category compare?

All NDC devices

NDC Calculator, Drug Dose: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NDC

2in 2025

2007: 12008: 22010: 12012: 22014: 32015: 32016: 22017: 82018: 32019: 12020: 52021: 32023: 32024: 32025: 22026 (partial year): 4
2007high 8 (2017) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NDC

60in 2024

2014: 118 days median2015: 199 days median2017: 189 days median2018: 220 days median2020: 53 days median2021: 269 days median2023: 126 days median2024: 60 days median2026 (partial year): 90 days median
2007high 269 (2021) · low 53 (2020)2026

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

Recalls per year · NDC

1in 2025

2016: 12017: 22018: 12019: 12022: 12025: 12026 (partial year): 2
2007high 2 (2017) · low 0 (2007)2026

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

Adverse event reports per year · NDC

299in 2025

2008: 72009: 42010: 182011: 112012: 22013: 12014: 12015: 12016: 182017: 252018: 212019: 182020: 102021: 112022: 3472023: 4632024: 1682025: 299
2007high 463 (2023) · low 0 (2007)2025

MAUDE reports naming product code NDC, 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—00
20082—07
20090—04
20101—018
20110—011
20122—02
20130—01
2014311801
2015319901
20162—118
20178189225
20183220121
20191—118
2020553010
20213269011
20220—1347
202331260463
20243600168
20252—1299
20264902—

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https://510kreport.com/device/K882001 · printed Nov 6, 2026

Cite this page

510(k) Report. “K882001: Diacare Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K882001

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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