510(k) · Cleared

Cleared

Drug Calibrator II

K982871510(k) TraditionalCleared Oct 13, 199860-day reviewClass II21 CFR 862.3200

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

Dade Behring, Inc. · DKB Calibrators, Drug Mixture

Cleared on Oct 13, 1998 as substantially equivalent to K962817 (Dade Intl., Inc., 1996) after a 60-day review. Its family tree reaches back 1 generation to 1996.

Decided: Oct 13, 1998
Review: 60 days
Class: Class II
Product code: DKB
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K962817 (1996). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK962817 Drug Calibrator IIDade Intl., Inc. · 1996
This deviceK982871 Drug Calibrator IIDade Behring, Inc. · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K962817	Drug Calibrator II	Dade Intl., Inc.	1996	—
0 (this device)	K982871	Drug Calibrator II	Dade Behring, Inc.	1998	—

FIG. 1 — Lineage of K982871, 1996–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DKB? 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? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K962817	Drug Calibrator II Summary page 1 …Newark, DE 19714-6101 Date of Preparation: 8/13/98 Device Name: Drug Calibrator Il Classification Name: Calibrator, Drug Mixture Predicate Device: Drug Calibrator Il (K962817) Device Description: Drug Calibrator Il (K962817) is being modified to add valproic acid as an additional constituent on the pro…	Dade Intl., Inc.	1996	—

What descends from it?

No later submission names this one as a predicate yet.

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?

Its one ancestor has no recall.

How does its category compare?

All DKB devices

DKB Calibrators, Drug Mixture: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DKB

2in 2014

2007high 2 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DKB

Too few DKB 510(k)s in any year since 2007 to give a median.

Recalls per year · DKB

2in 2022

2007high 3 (2009) · low 0 (2007)2026

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

Adverse event reports per year · DKB

1in 2017

2007high 4 (2012) · low 0 (2007)2025

MAUDE reports naming product code DKB, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	0
2008	0	—	0	0
2009	2	—	3	0
2010	0	—	0	0
2011	2	—	2	1
2012	1	—	1	4
2013	0	—	0	0
2014	2	—	0	0
2015	0	—	0	0
2016	0	—	0	0
2017	0	—	0	1
2018	0	—	0	0
2019	0	—	0	0
2020	0	—	0	0
2021	0	—	0	0
2022	0	—	2	0
2023	0	—	0	0
2024	0	—	0	0
2025	0	—	0	0
2026	0	—	0	—

What is it indicated for?

Drug Calibrator Il is an in vitro diagnostic product intended for use in an in vitro test system to establish points of reference that are used in the determination of values in the measurement of human substances.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K982871 · printed Nov 6, 2026

Cite this page

510(k) Report. “K982871: Drug Calibrator II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982871

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026