510(k) · Cleared
ClearedPharmacia Cap System Rast Ria & Rast Feia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pharmacia, Inc. · DHB System, Test, Radioallergosorbent (Rast) Immunological
Cleared on Jan 22, 1990 after a 220-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Jan 22, 1990
- Review
- 220 days
- Class
- Class II
- Product code
- DHB
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK894190 Pharmacia Cap System Rast Ria & Rast FeiaPharmacia, Inc. · 1990
- Descendant · cites it directly · 2 of its ownK991048 Allergen Immunocap, Models E7, F93, F94, F95, F203, F204, F208…Pharmacia & Upjohn Co. · 1999
- Descendant · 2 generations on · 1 of its ownK113841 Immunocap Allergen Components BundlePhadia US, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK974580 Allergen Immunocap F256,F245,F207,F202Pharmacia & Upjohn Co. · 1998
- Descendant · 3 generations on · 0 of its ownK151029 Phadia PrimePhadia AB · 2016 · Recalled
- Descendant · 2 generations on · 0 of its ownK150854 ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP…Phadia AB · 2015
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K991048Allergen Immunocap, Models E7, F93, F94, F95, F203, F204, F208, F209, F210, F214, F216…Pharmacia & Upjohn Co. · 1999 · cites it directly2descendants
- K113841Immunocap Allergen Components BundlePhadia US, Inc. · 2012 · 2 generations on1descendant
- K974580Allergen Immunocap F256,F245,F207,F202Pharmacia & Upjohn Co. · 1998 · cites it directly1descendant
- K151029Phadia PrimePhadia AB · 2016 · 3 generations on0descendants
- K150854ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP Allergen f440…Phadia AB · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +2 | K113841 | Immunocap Allergen Components Bundle | Phadia US, Inc. | 2012 | — |
| +1 | K974580 | Allergen Immunocap F256,F245,F207,F202 | Pharmacia & Upjohn Co. | 1998 | — |
| +3 | K151029 | Phadia Prime | Phadia AB | 2016 | 1 |
| +2 | K150854 | ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP Allergen… | Phadia AB | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K991048 (Pharmacia & Upjohn Co., 1999) has gone furthest, with 2 descendants of its own.
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 | — |
https://510kreport.com/device/K894190 · printed Nov 4, 2026
Cite this page
510(k) Report. “K894190: Pharmacia Cap System Rast Ria & Rast Feia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K894190
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026