510(k) · Cleared
ClearedImmunocap Rapid Inhalant Profile , Immunocap Rapid Reader, Immunocap Rapid Reader Check Device, and Immunocap Rapid QC1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phadia AB · DHB System, Test, Radioallergosorbent (Rast) Immunological
Cleared on Mar 16, 2009 as substantially equivalent to K962274 (Pharmacia, Inc., 1996) after a 259-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it.
- Decided
- Mar 16, 2009
- Review
- 259 days
- Class
- Class II
- Product code
- DHB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K962274 (1996). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K092978Immunocap Rapid Reader, Model 12-3600-10Phadia US, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K962274 | Unicap 100 | Pharmacia, Inc. | 1996 | — |
| 0 (this device) | K081830 | Immunocap Rapid Inhalant Profile , Immunocap Rapid Reader, Immunocap Rapid… | Phadia AB | 2009 | — |
| +1 | K092978 | Immunocap Rapid Reader, Model 12-3600-10 | Phadia US, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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? (1)
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 |
|---|---|---|---|
| * | K962274 | Unicap 100Summary page 1….5750 Product Class: Class II Product Code: DHB Substantial Equivalence to: lmmunoCAPO Specific IgE (K962274) Phadia Intended Use ImmunoCAP Rapid Inhalant Profile 1, part of the ImmunoCAP Rapid System, is an in vitro semi-… | 1996 |
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 |
|---|---|---|---|
| K092978 | Immunocap Rapid Reader, Model 12-3600-10 | 2010 | 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?
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. 2009, 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 Rapid Inhalant Profile 1, part of the ImmunoCAP Rapid System, is an in vitro semiquantitative assay for measurement of allergen specific IgE to ten inhalant allergens (house dust mite, cat, dog, mold, and pollen from common ragweed, Bermuda grass, timothy grass, oak, and elm) in heparinized human capillary whole blood, heparinized venous whole blood, or heparinized plasma. 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, licensed under CLIA to perform nonwaived assays.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081830 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081830: Immunocap Rapid Inhalant Profile , Immunocap Rapid Reader, Immunocap Rapid Reader Check Device, and Immunocap Rapid QC1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081830
Report an extraction error
Are you the manufacturer?
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