510(k) · Cleared
Recalled · Class II · 2018HY-Tec Specific and Total Ige Eia System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hycor Biomedical, Inc. · DHB System, Test, Radioallergosorbent (Rast) Immunological
Cleared on May 22, 2008 as substantially equivalent to K941278 (Hycor Biomedical, Inc., 1995) after a 22-day review. Its family tree reaches back 1 generation to 1995. It has been recalled once.
- Decided
- May 22, 2008
- Review
- 22 days
- Class
- Class II
- Product code
- DHB
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K941278 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK941278 HY-Tec Automated Eia SystemHycor Biomedical, Inc. · 1995 · Recalled
- This deviceK081217 HY-Tec Specific and Total Ige Eia SystemHycor Biomedical, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K941278 | HY-Tec Automated Eia System | Hycor Biomedical, Inc. | 1995 | 1 |
| 0 (this device) | K081217 | HY-Tec Specific and Total Ige Eia System | Hycor Biomedical, Inc. | 2008 | — |
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 |
|---|---|---|---|
| * | K941278 | HY-Tec Automated Eia SystemSummary page 1…ce Name: We are claiming substantial equivalence to the The HY*TECTM Automated EIA System for Total IgE and Specific IgE, MCS Assay, cleared 5 10(k) K941278. 4. Intended Use of the Device: The HYOTECTM Specific and Total IgE EIA System is an enzyme immunoassay… | 1995 |
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 |
|---|---|---|---|---|
| Jul 25, 2018 | Class II | Z-0224-2020 | Employee error | Some of the Stop Solution bottles, a caustic solution, have been reported to leak. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 1 other device also cites its predicate K941278.
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. 2008, 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?
The HYoTECTM Specific and Total IgE EIA System is an enzyme immunoassay (EIA) method for the quantitative determination of allergen-specific and/or total IgE concentrations in human serum. The assay is to be used with the HYoTECTM 288 instrument for in-vitro diagnostic use. Measurement of specific allergen antibodies and total IgE may aid in the diagnosis of asthma, allergies and other pulmonary disorders.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081217 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081217: HY-Tec Specific and Total Ige Eia System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081217
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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