510(k) · Cleared
Recalled · Class II · 2017Allergen Immundocap MODELC5, C6, C73, E201, E213, F50, F51,F54, F55, F56, F57, F58, F59, F60, F61, F205, F213, F218, F
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 Dec 1, 1999 as substantially equivalent to K894190 (Pharmacia, Inc., 1990) and 2 other predicates after a 54-day review. Its family tree reaches back 1 generation to 1990. It has been recalled 2 times.
- Decided
- Dec 1, 1999
- Review
- 54 days
- Class
- Class II
- Product code
- DHB
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 1 generation to K894190 (1990). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK894190 Pharmacia Cap System Rast Ria & Rast FeiaPharmacia, Inc. · 1990
- This deviceK993388 Allergen Immundocap MODELC5, C6, C73, E201, E213, F50, F51,F54, F55…Pharmacia & Upjohn Co. · 1999
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) | K993388 | Allergen Immundocap MODELC5, C6, C73, E201, E213, F50, F51,F54, F55, F56, F57… | Pharmacia & Upjohn Co. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1996 | 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…2, £233, {244, £254, £299, £x7, £x13, £x14, fx15, 18, £20, g201, gx3, gx4, 18,173, 1201, m207, ol, p4, 1208, tx6, tx9, wx3 Predi ¢ f i D Pharmacia CAP System™ RAST FEIA K894190, K911903 UniCAP™ Specific IgE Assay K962274 Intepded Use Statement : Allergen JmmunoCAP™ is the solid phase component of the P… | 1990 |
| * | K911903 | Allergans Pharmacia Cap Sys.Rast Ria/FeiaSummary page 2…{244, £254, £299, £x7, £x13, £x14, fx15, 18, £20, g201, gx3, gx4, 18,173, 1201, m207, ol, p4, 1208, tx6, tx9, wx3 Predi ¢ f i D Pharmacia CAP System™ RAST FEIA K894190, K911903 UniCAP™ Specific IgE Assay K962274 Intepded Use Statement : Allergen JmmunoCAP™ is the solid phase component of the Pharmacia… | 1991 |
| * | K962274 | Unicap 100Summary page 2…x15, 18, £20, g201, gx3, gx4, 18,173, 1201, m207, ol, p4, 1208, tx6, tx9, wx3 Predi ¢ f i D Pharmacia CAP System™ RAST FEIA K894190, K911903 UniCAP™ Specific IgE Assay K962274 Intepded Use Statement : Allergen JmmunoCAP™ is the solid phase component of the Pharmacia & Upjohn in vitro immunodiagnostic s… | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 18, 2017 | Class II | Z-1312-2018 | Device Design | The stability specifications of ImmunoCAP Allergen c5, Ampicilloyl were not met. |
| Dec 18, 2017 | Class II | Z-1313-2018 | Device Design | The stability specifications of ImmunoCAP Allergen c6, Amoxicilloyl were not met. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K894190.
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/K993388 · printed Nov 5, 2026
Cite this page
510(k) Report. “K993388: Allergen Immundocap MODELC5, C6, C73, E201, E213, F50, F51,F54, F55, F56, F57, F58, F59, F60, F61, F205, F213, F218, F.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993388
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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