510(k) · Cleared
ClearedIQ Chambers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dormer Laboratories, Inc. · KXF Applicator, Absorbent Tipped, Non-Sterile
Cleared on Apr 12, 2000 as substantially equivalent to K811365 (Hill Top Research, Inc., 1981) after a 257-day review. Its family tree reaches back 1 generation to 1981. 1 later device descends from it.
- Decided
- Apr 12, 2000
- Review
- 257 days
- Class
- Class I
- Product code
- KXF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K811365 (1981). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K013820Finn Chamber (R)Epitest Ltd. OY · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K811365 | Hill Top Chamber | Hill Top Research, Inc. | 1981 | — |
| 0 (this device) | K992553 | IQ Chambers | Dormer Laboratories, Inc. | 2000 | — |
| +1 | K013820 | Finn Chamber (R) | Epitest Ltd. OY | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 KXF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K811365 | Hill Top ChamberSummary page 5…h hazard when used according to directions. The device is substantially equivalent to various marketed allergen and vaccine delivery systems including Hill Top Chambers (K811365) | 1981 |
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 |
|---|---|---|---|
| K013820 | Finn Chamber (R) | 2002 | 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?
- Its one ancestor has no recall.
- Of its descendants, K013820 (Epitest Ltd. OY, 2002) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KXF devicesKXF Applicator, Absorbent Tipped, Non-Sterile: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KXF
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · KXF
Too few KXF 510(k)s in any year since 2007 to give a median.
Recalls per year · KXF
No recall names KXF since 2007.
Adverse event reports per year · KXF
5in 2025
MAUDE reports naming product code KXF, 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 | 0 | — | 0 | 11 |
| 2008 | 0 | — | 0 | 13 |
| 2009 | 0 | — | 0 | 7 |
| 2010 | 0 | — | 0 | 15 |
| 2011 | 1 | — | 0 | 42 |
| 2012 | 1 | — | 0 | 37 |
| 2013 | 0 | — | 0 | 34 |
| 2014 | 0 | — | 0 | 14 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 0 | — | 0 | 11 |
| 2017 | 0 | — | 0 | 18 |
| 2018 | 0 | — | 0 | 9 |
| 2019 | 0 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 64 |
| 2021 | 0 | — | 0 | 134 |
| 2022 | 0 | — | 0 | 13 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The 1Q Chamber is an allergen delivery system which places allergens or allergen mixes in contact with the surface of the skin for the purpose of performing patch testing.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992553 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992553: IQ Chambers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992553
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