510(k) · Cleared
ClearedAlastat Microplate Latex-Specific Ige Allergen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Products Corp. · DHB System, Test, Radioallergosorbent (Rast) Immunological
Cleared on Aug 15, 1995 after a 47-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Aug 15, 1995
- Review
- 47 days
- Class
- Class II
- Product code
- DHB
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK953014 Alastat Microplate Latex-Specific Ige AllergenDiagnostic Products Corp. · 1995
- Descendant · cites it directly · 4 of its ownK962976 Pharmacia Cap System Rast FeiaPharmacia & Upjohn Co. · 1996
- Descendant · 2 generations on · 3 of its ownK972068 Unicap Specific Ige Feia Assay, Latex Allergen Immunocap K82Pharmacia, Inc. · 1997
- Descendant · 3 generations on · 1 of its ownK030590 Cla Allergen-Specific Ige Assay-Latex Allergen (K82)Hitachi Chemical Diagnostics, Inc. · 2003
- Descendant · 3 generations on · 0 of its ownK121463 Immunocap Allergen K82Thermo Fisher Scientific · 2013 · Recalled
- Descendant · 4 generations on · 0 of its ownK051677 Optigen Allergen Specific Ige AssayHitachi Chemical Diagnostics, Inc. · 2006 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K962976Pharmacia Cap System Rast FeiaPharmacia & Upjohn Co. · 1996 · cites it directly4descendants
- K972068Unicap Specific Ige Feia Assay, Latex Allergen Immunocap K82Pharmacia, Inc. · 1997 · 2 generations on3descendants
- K030590Cla Allergen-Specific Ige Assay-Latex Allergen (K82)Hitachi Chemical Diagnostics, Inc. · 2003 · 3 generations on1descendant
- K121463Immunocap Allergen K82Thermo Fisher Scientific · 2013 · 3 generations on0descendants
- K051677Optigen Allergen Specific Ige AssayHitachi Chemical Diagnostics, Inc. · 2006 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K953014 | Alastat Microplate Latex-Specific Ige Allergen | Diagnostic Products Corp. | 1995 | — |
| +1 | K962976 | Pharmacia Cap System Rast Feia | Pharmacia & Upjohn Co. | 1996 | — |
| +2 | K972068 | Unicap Specific Ige Feia Assay, Latex Allergen Immunocap K82 | Pharmacia, Inc. | 1997 | — |
| +3 | K030590 | Cla Allergen-Specific Ige Assay-Latex Allergen (K82) | Hitachi Chemical Diagnostics, Inc. | 2003 | — |
| +3 | K121463 | Immunocap Allergen K82 | Thermo Fisher Scientific | 2013 | 1 |
| +4 | K051677 | Optigen Allergen Specific Ige Assay | Hitachi Chemical Diagnostics, Inc. | 2006 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2013 | 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? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K962976 | Pharmacia Cap System Rast Feia | 1996 | 4 |
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, K962976 (Pharmacia & Upjohn Co., 1996) has gone furthest, with 4 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/K953014 · printed Nov 6, 2026
Cite this page
510(k) Report. “K953014: Alastat Microplate Latex-Specific Ige Allergen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K953014
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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