510(k) Report

510(k) · Cleared

Cleared

Para Check (Aka Eight Check-C)

K852992510(k) TraditionalCleared Oct 10, 198587-day reviewClass II21 CFR 864.8625

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

Streck Laboratories, Inc. · JPK Mixture, Hematology Quality Control

Cleared on Oct 10, 1985 after an 87-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Oct 10, 1985
Review
87 days
Class
Class II
Product code
JPK
Recalls
None
Predicates
0

3 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2015: 1 descendant cleared2017: 1 descendant cleared2022: 1 descendant cleared1990200020102020
  1. This deviceK852992 Para Check (Aka Eight Check-C)Streck Laboratories, Inc. · 1985
  2. Descendant · cites it directly · 2 of its ownK143577 XW-100 Automated Hematology Analyzer, XW QC CHECKSysmex America, Inc. · 2015
  3. Descendant · 2 generations on · 1 of its ownK172604 XW-100 Automated Hematology Analyzer for CLIA Waived UseSysmex America, Inc. · 2017
  4. Descendant · 3 generations on · 0 of its ownK210346 Sysmex XW-100 Automated Hematology AnalyzerSysmex America, Inc. · 2022

Most influential descendants

Showing 3 of 3 · See all
  • K143577XW-100 Automated Hematology Analyzer, XW QC CHECKSysmex America, Inc. · 2015 · cites it directly2descendants
  • K172604XW-100 Automated Hematology Analyzer for CLIA Waived UseSysmex America, Inc. · 2017 · 2 generations on1descendant
  • K210346Sysmex XW-100 Automated Hematology AnalyzerSysmex America, Inc. · 2022 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K852992Para Check (Aka Eight Check-C)Streck Laboratories, Inc.1985—
+1K143577XW-100 Automated Hematology Analyzer, XW QC CHECKSysmex America, Inc.2015—
+2K172604XW-100 Automated Hematology Analyzer for CLIA Waived UseSysmex America, Inc.2017—
+3K210346Sysmex XW-100 Automated Hematology AnalyzerSysmex America, Inc.2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201710
202210
FIG. 1 — Lineage of K852992, 1985–2022Source: 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 JPK? 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? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K143577XW-100 Automated Hematology Analyzer, XW QC CHECKSysmex America, Inc.20152

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, K143577 (Sysmex America, Inc., 2015) has gone furthest, with 2 descendants of its own.

How does its category compare?

All JPK devices

JPK Mixture, Hematology Quality Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JPK

4in 2016

2007: 52009: 52010: 42011: 12012: 22013: 12014: 22016: 4
2007high 5 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JPK

296in 2016

2007: 44 days median2009: 187 days median2010: 267 days median2016: 296 days median
2007high 296 (2016) · low 44 (2007)2026

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

Recalls per year · JPK

1in 2022

2007: 12010: 22011: 32012: 12020: 12021: 22022: 1
2007high 3 (2011) · low 0 (2008)2026

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

Adverse event reports per year · JPK

2in 2023

2007: 142008: 12010: 52011: 562012: 22014: 12019: 12020: 12021: 12023: 2
2007high 56 (2011) · low 0 (2009)2025

MAUDE reports naming product code JPK, 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
2007544114
20080—01
2009518700
2010426725
20111—356
20122—12
20131—00
20142—01
20150—00
2016429600
20170—00
20180—00
20190—01
20200—11
20210—21
20220—10
20230—02
20240—00
20250—00
20260—0—

More from Streck Laboratories, Inc.

70 FDA decisions under this applicant name. See the company

  • K042587Retic-Chex for Cell-DynStreck Laboratories, Inc. · 2004
  • K040107Cyto-Chex BCTStreck Laboratories, Inc. · 2004
  • K040025A1C-CellularStreck Laboratories, Inc. · 2004
  • K023656Sickle-Chex Solubility KitStreck Laboratories, Inc. · 2002
  • K021922Modification to Para 5XStreck Laboratories, Inc. · 2002

Recent decisions in JPK

The JPK category page

  • K160590XN CheckStreck · 2016
  • K160588XN Check BFStreck · 2016
  • K160586XN-L CheckStreck · 2016
  • K160606BC-5D Hematology ControlR&D Systems, Inc. · 2016
  • K141964XN CheckStreck · 2014

https://510kreport.com/device/K852992 · printed Nov 4, 2026

Cite this page

510(k) Report. “K852992: Para Check (Aka Eight Check-C).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K852992

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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