510(k) · Cleared
ClearedImmunocap Allergen Components Bundle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phadia US, Inc. · DHB System, Test, Radioallergosorbent (Rast) Immunological
Cleared on Sep 13, 2012 as substantially equivalent to K051218 (Pharmacia Diagnostics AB, 2005) and 2 other predicates after a 260-day review. Its family tree reaches back 2 generations to 1990. 1 later device descends from it.
- Decided
- Sep 13, 2012
- Review
- 260 days
- Class
- Class II
- Product code
- DHB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K894190 (1990). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK894190 Pharmacia Cap System Rast Ria & Rast FeiaPharmacia, Inc. · 1990
- 1 generation backK991048 Allergen Immunocap, Models E7, F93, F94, F95, F203, F204, F208…Pharmacia & Upjohn Co. · 1999
- This deviceK113841 Immunocap Allergen Components BundlePhadia US, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK151029 Phadia PrimePhadia AB · 2016 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K151029Phadia PrimePhadia AB · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K894190 | Pharmacia Cap System Rast Ria & Rast Feia | Pharmacia, Inc. | 1990 | — |
| −1 | K991048 | Allergen Immunocap, Models E7, F93, F94, F95, F203, F204, F208, F209, F210… | Pharmacia & Upjohn Co. | 1999 | — |
| 0 (this device) | K113841 | Immunocap Allergen Components Bundle | Phadia US, Inc. | 2012 | — |
| +1 | K151029 | Phadia Prime | Phadia AB | 2016 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K051218 | Modification to: Unicap Specific Ige | 2005 |
| * | K962274 | Unicap 100Summary page 2…11 CFR 866.5750 Substantial Equivalence to: ImmunoCAP Specific IgE (kOS51218) UniCAP 100 (k962274) ImmunoCAP Allergen f95, Peach (k991048) Indications For Use Statement ImmunoCAP Specific IgE is an in vitro quantitati… | 1996 |
| * | K991048 | Allergen Immunocap, Models E7, F93, F94, F95, F203, F204, F208, F209, F210, F214, F216…Summary page 2…5750 Substantial Equivalence to: ImmunoCAP Specific IgE (kOS51218) UniCAP 100 (k962274) ImmunoCAP Allergen f95, Peach (k991048) Indications For Use Statement ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specifi… | 1999 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151029 | Phadia Prime | 2016 | 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?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 13.3 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K151029 (Phadia AB, 2016) has gone furthest, with 0 descendants of its own.
- 26 other devices also cite its predicate K051218.
How does its category compare?
All DHB devicesDHB System, Test, Radioallergosorbent (Rast) Immunological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · DHB
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DHB
90in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DHB
14in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DHB
6in 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?
ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma (EDTA or Na-Heparin). ImmunoCAP Specific IgE is to be used with instruments Phadia 100, Phadia 250, and Phadia 1000. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings, and is to be used in clinical laboratories.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113841 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113841: Immunocap Allergen Components Bundle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113841
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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