510(k) · Cleared

Cleared

Allergen Immunocap F256,F245,F207,F202

K974580510(k) TraditionalCleared Feb 9, 199863-day reviewClass II21 CFR 866.5750

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

Pharmacia & Upjohn Co. · DHB System, Test, Radioallergosorbent (Rast) Immunological

Cleared on Feb 9, 1998 as substantially equivalent to K894190 (Pharmacia, Inc., 1990) and 2 other predicates after a 63-day review. Its family tree reaches back 1 generation to 1990. 1 later device descends from it.

Decided: Feb 9, 1998
Review: 63 days
Class: Class II
Product code: DHB
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K894190 (1990). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK894190 Pharmacia Cap System Rast Ria & Rast FeiaPharmacia, Inc. · 1990
This deviceK974580 Allergen Immunocap F256,F245,F207,F202Pharmacia & Upjohn Co. · 1998
Descendant · cites it directly · 0 of its ownK150854 ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP…Phadia AB · 2015

Most influential descendants

Showing 1 of 1 · See all

K150854ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP Allergen f440…Phadia AB · 2015 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K894190	Pharmacia Cap System Rast Ria & Rast Feia	Pharmacia, Inc.	1990	—
0 (this device)	K974580	Allergen Immunocap F256,F245,F207,F202	Pharmacia & Upjohn Co.	1998	—
+1	K150854	ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP Allergen…	Phadia AB	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0
1996	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	1	0

FIG. 1 — Lineage of K974580, 1990–2015Source: 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 DHB? 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 DHB device

#1 K260331 IMMULITE 2000 3gAllergy Specific IgE Vantage…score 12.3 · 2 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (3)

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
*	K894190	Pharmacia Cap System Rast Ria & Rast Feia Summary page 2 …fety and Effectiveness Classification: Product Name Product Code Class CFR Allergen ImmunoCAP™ 82 DHB I 866.5750 256, 245, £207, £202 Pharmacia CAP System™ RAST FEIA K894190, K911903 UniCAP™ Specific IgE Assay K962274 Intended Use Statement : Allergen ImmunoCAP™ is the solid phase component of the Ph…	Pharmacia, Inc.	1990	—
*	K911903	Allergans Pharmacia Cap Sys.Rast Ria/Feia Summary page 2 …Effectiveness Classification: Product Name Product Code Class CFR Allergen ImmunoCAP™ 82 DHB I 866.5750 256, 245, £207, £202 Pharmacia CAP System™ RAST FEIA K894190, K911903 UniCAP™ Specific IgE Assay K962274 Intended Use Statement : Allergen ImmunoCAP™ is the solid phase component of the Pharmacia &…	Pharmacia, Inc.	1991	—
*	K962274	Unicap 100 Summary page 2 …uct Name Product Code Class CFR Allergen ImmunoCAP™ 82 DHB I 866.5750 256, 245, £207, £202 Pharmacia CAP System™ RAST FEIA K894190, K911903 UniCAP™ Specific IgE Assay K962274 Intended Use Statement : Allergen ImmunoCAP™ is the solid phase component of the Pharmacia & Upjohn in vitro immunodiagnostic s…	Pharmacia, Inc.	1996	—

Also cleared against K894190: 2 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K150854	ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP Allergen f440…	Phadia AB	2015	0

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?

None of the 3 ancestors has a recall.
Of its descendants, K150854 (Phadia AB, 2015) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K894190.

How does its category compare?

All DHB devices

DHB System, Test, Radioallergosorbent (Rast) Immunological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DHB

2in 2025

2007high 7 (2009) · low 0 (2023)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DHB

90in 2019

2007high 405 (2011) · low 90 (2019)2026

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

Recalls per year · DHB

14in 2025

2007high 14 (2025) · low 0 (2007)2026

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

Adverse event reports per year · DHB

6in 2025

2007high 11 (2017) · low 0 (2007)2025

MAUDE reports naming product code DHB, 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	1	—	0	0
2008	2	—	0	1
2009	7	118	0	0
2010	3	247	0	0
2011	5	405	0	1
2012	3	260	1	2
2013	5	257	0	0
2014	1	—	1	0
2015	1	—	0	1
2016	2	—	0	0
2017	1	—	1	11
2018	2	—	1	6
2019	3	90	0	4
2020	2	—	0	0
2021	1	—	0	7
2022	2	—	3	1
2023	0	—	0	6
2024	0	—	0	10
2025	2	—	14	6
2026	6	138	0	—

What is it indicated for?

Allergen ImmunoCAP™ is the solid phase component of the Pharmacia & Upjohn in vitro immunodiagnostic systems which measure specific IgE to the respective allergen bound to the InmunoCAP™. Allergen ImmunoCAP™ are intended to be used with Pharmacia CAP System™ RAST FEIA and UniCAP™ Specific IgE in vitro diagnostic assays.

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/K974580 · printed Nov 4, 2026

Cite this page

510(k) Report. “K974580: Allergen Immunocap F256,F245,F207,F202.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974580

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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