510(k) Report

510(k) · Cleared

Cleared

Wako CRP-UL, CRP-UL Calibrator Set

K003342510(k) TraditionalCleared Jan 22, 200189-day reviewClass II21 CFR 866.5270

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

Wako Chemicals USA, Inc. · DCN System, Test, C-Reactive Protein

Cleared on Jan 22, 2001 after an 89-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Jan 22, 2001
Review
89 days
Class
Class II
Product code
DCN
Recalls
None
Predicates
0

2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2002: 2 descendants cleared200020052010201520202025
  1. This deviceK003342 Wako CRP-UL, CRP-UL Calibrator SetWako Chemicals USA, Inc. · 2001
  2. Descendant · cites it directly · 0 of its ownK021882 Crpex-HS CRP Calibrator Set, Catalog NO: 1510Good Biotech Corp. · 2002
  3. Descendant · cites it directly · 0 of its ownK020603 Crpex-HS C-Reactive Protein Lit Assay, Catalog NO. 1010Good Biotech Corp. · 2002

Most influential descendants

Showing 2 of 2 · See all
  • K021882Crpex-HS CRP Calibrator Set, Catalog NO: 1510Good Biotech Corp. · 2002 · cites it directly0descendants
  • K020603Crpex-HS C-Reactive Protein Lit Assay, Catalog NO. 1010Good Biotech Corp. · 2002 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003342Wako CRP-UL, CRP-UL Calibrator SetWako Chemicals USA, Inc.2001—
+1K021882Crpex-HS CRP Calibrator Set, Catalog NO: 1510Good Biotech Corp.2002—
+1K020603Crpex-HS C-Reactive Protein Lit Assay, Catalog NO. 1010Good Biotech Corp.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
FIG. 1 — Lineage of K003342, 2001–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 DCN? 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 DCN device

  1. #1 K232624 CardioPhase® hsCRPscore 6.7 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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? (2)

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

NumberDeviceApplicantDecidedDescendants
K021882Crpex-HS CRP Calibrator Set, Catalog NO: 1510Good Biotech Corp.20020
K020603Crpex-HS C-Reactive Protein Lit Assay, Catalog NO. 1010Good Biotech Corp.20020

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, K021882 (Good Biotech Corp., 2002) has gone furthest, with 0 descendants of its own.

How does its category compare?

All DCN devices

DCN System, Test, C-Reactive Protein: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DCN

2in 2023

2007: 12008: 22009: 32010: 12012: 12017: 12018: 32020: 12023: 2
2007high 3 (2009) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DCN

234in 2018

2009: 111 days median2018: 234 days median
2007high 234 (2018) · low 111 (2009)2026

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

Recalls per year · DCN

1in 2020

2008: 12019: 12020: 12026 (partial year): 1
2007high 1 (2008) · low 0 (2007)2026

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

Adverse event reports per year · DCN

7in 2025

2010: 22011: 52012: 22014: 22015: 22016: 12018: 22019: 82021: 12022: 12023: 32024: 52025: 7
2007high 8 (2019) · low 0 (2007)2025

MAUDE reports naming product code DCN, 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—10
2009311100
20101—02
20110—05
20121—02
20130—00
20140—02
20150—02
20160—01
20171—00
2018323402
20190—18
20201—10
20210—01
20220—01
20232—03
20240—05
20250—07
20260—1—

More from Wako Chemicals USA, Inc.

124 FDA decisions under this applicant name. See the company

  • K100464Utaswako I30 (Includes Accessories), Utaswako Afp-L3, Calibrator Set, Control L, Control H, Sample DilutionWako Chemicals USA, Inc. · 20112 recalls
  • K080125Apolowako T-Cho, HDL-C, TG and Analyzer, Models 993-23501, 999-23601, 995-23701 and 993-25201Wako Chemicals USA, Inc. · 2008
  • K080123Apolowako HBA1C, Glucose and Analyzer, Models 993-24601, 991-24401 and 993-25201Wako Chemicals USA, Inc. · 2008
  • K061775Wako L-Type Creatinine-M Test, and Wako Creatinine CalibratorWako Chemicals USA, Inc. · 2007
  • K062368Wako Lba DCP Test System, Model 993-05301; DCP Control Set, Model 995-0551; DCP Calibrator Set, Libasys…Wako Chemicals USA, Inc. · 2007

Recent decisions in DCN

The DCN category page

  • K232624CardioPhase® hsCRPSiemens Healthcare Diagnostic Products GmbH · 2023
  • K221119RCRP Flex reagent cartridgeSiemens Healthcare Diagnostics, Inc. · 20232 recalls
  • K192072Tina-quant C-Reactive Protein IVRoche Diagnostics Operations (Rdo) · 2020
  • K180099Optilite High Sensitivity C-Reactive Protein KitThe Binding Site Group, Ltd. · 2018
  • K172868Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein…The Binding Site Group, Ltd. · 20181 recall

https://510kreport.com/device/K003342 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003342: Wako CRP-UL, CRP-UL Calibrator Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003342

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026