510(k) · Cleared
ClearedAllergen Immunocap, Models E7, F93, F94, F95, F203, F204, F208, F209, F210, F214, F216, F235, F237, F242, F255, F259, F2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pharmacia & Upjohn Co. · DHB System, Test, Radioallergosorbent (Rast) Immunological
Cleared on May 14, 1999 as substantially equivalent to K894190 (Pharmacia, Inc., 1990) and 2 other predicates after a 45-day review. Its family tree reaches back 1 generation to 1990. 2 later devices descend from it.
- Decided
- May 14, 1999
- Review
- 45 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. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK894190 Pharmacia Cap System Rast Ria & Rast FeiaPharmacia, Inc. · 1990
- This deviceK991048 Allergen Immunocap, Models E7, F93, F94, F95, F203, F204, F208…Pharmacia & Upjohn Co. · 1999
- Descendant · cites it directly · 1 of its ownK113841 Immunocap Allergen Components BundlePhadia US, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK151029 Phadia PrimePhadia AB · 2016 · Recalled
Most influential descendants
Showing 2 of 2 · See allView 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) | K991048 | Allergen Immunocap, Models E7, F93, F94, F95, F203, F204, F208, F209, F210… | Pharmacia & Upjohn Co. | 1999 | — |
| +1 | K113841 | Immunocap Allergen Components Bundle | Phadia US, Inc. | 2012 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K894190 | Pharmacia Cap System Rast Ria & Rast FeiaSummary page 2…5, £259, £260, £280, 284, £290, 202, k84, m202, m205, 1210, fx23, fx24, £x25 Predicate Test Systems For The Measurement of Specific IgE Pharmacia CAP System™ RAST FEIA K894190, K911903 UniCAP™ Specific IgE Assay K962274 Gr3.2sc7 03/23/99 Allergen ImmunoCAP™ 202 510(k) Submission Section… | 1990 |
| * | K911903 | Allergans Pharmacia Cap Sys.Rast Ria/FeiaSummary page 2…£260, £280, 284, £290, 202, k84, m202, m205, 1210, fx23, fx24, £x25 Predicate Test Systems For The Measurement of Specific IgE Pharmacia CAP System™ RAST FEIA K894190, K911903 UniCAP™ Specific IgE Assay K962274 Gr3.2sc7 03/23/99 Allergen ImmunoCAP™ 202 510(k) Submission Section 7. Summa… | 1991 |
| * | K962274 | Unicap 100Summary page 2…02, m205, 1210, fx23, fx24, £x25 Predicate Test Systems For The Measurement of Specific IgE Pharmacia CAP System™ RAST FEIA K894190, K911903 UniCAP™ Specific IgE Assay K962274 Gr3.2sc7 03/23/99 Allergen ImmunoCAP™ 202 510(k) Submission Section 7. Summary of Safety and Effectiveness Int… | 1996 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113841 | Immunocap Allergen Components Bundle | 2012 | 1 |
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?
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.
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?
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 ImmunoCAP. Allergen ImmunoCAP are intended to be used with Pharmacia CAP System RAST FEIA and UniCAP Specific IgE in vitro diagnostic assays.
Pharmacia CAP System RAST® FEIA and UniCAP® Specific IgE are intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other findings, and are to be used in clinical laboratories, as well as, physician office laboratories.
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/K991048 · printed Nov 5, 2026
Cite this page
510(k) Report. “K991048: Allergen Immunocap, Models E7, F93, F94, F95, F203, F204, F208, F209, F210, F214, F216, F235, F237, F242, F255, F259, F2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991048
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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