510(k) · Cleared
ClearedKenota 1 Total IgE; Kenota 1 (instrument)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kenota, Inc. · DGC Ige, Antigen, Antiserum, Control
Cleared on May 31, 2024 as substantially equivalent to K161899 (Phadia AB, 2016) after a 403-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- May 31, 2024
- Review
- 403 days
- Class
- Class II
- Product code
- DGC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K962274 (1996). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK962274 Unicap 100Pharmacia, Inc. · 1996
- 2 generations backK051218 Modification to: Unicap Specific IgePharmacia Diagnostics AB · 2005 · Recalled
- 1 generation backK161899 ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip…Phadia AB · 2016 · Recalled
- This deviceK231151 Kenota 1 Total IgE; Kenota 1 (instrument)Kenota, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K962274 | Unicap 100 | Pharmacia, Inc. | 1996 | — |
| −2 | K051218 | Modification to: Unicap Specific Ige | Pharmacia Diagnostics AB | 2005 | 3 |
| −1 | K161899 | ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP… | Phadia AB | 2016 | 1 |
| 0 (this device) | K231151 | Kenota 1 Total IgE; Kenota 1 (instrument) | Kenota, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2014 | 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 DGC? 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 DGC device
- #1 K214068 Quantia IgEscore 5.2 · 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 |
|---|---|---|---|
| * | K161899 | ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE…Summary page 8…on is performed. IV Substantial Equivalence Information: A Predicate Device Name: Phadia ImmunoCAP Total IgE B Predicate 510(k) Number: K161899 C Comparison with Predicate(s): Device & Predicate Candidate… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 28 years and passes through 4 companies; a new generation was cleared every 8.7 years on median.
- 3 of the 5 ancestors have a recall of any class.
How does its category compare?
All DGC devicesDGC Ige, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · DGC
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DGC
Too few DGC 510(k)s in any year since 2007 to give a median.
Recalls per year · DGC
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DGC
2in 2021
MAUDE reports naming product code DGC, 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 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 1 | 5 |
| 2010 | 0 | — | 0 | 12 |
| 2011 | 0 | — | 0 | 13 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 1 | — | 1 | 2 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Kenota 1 Total IgE is an in vitro test system intended for semi-quantitative measurement of total IgE in human capillary whole blood on the Kenota 1 instrument. 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 allergist/immunologist offices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231151 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231151: Kenota 1 Total IgE; Kenota 1 (instrument).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231151
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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