510(k) · Cleared

Cleared

Finn Chamber (R)

K013820510(k) TraditionalCleared Jan 30, 200275-day reviewClass I21 CFR 880.6025

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Epitest Ltd. OY · KXF Applicator, Absorbent Tipped, Non-Sterile

Cleared on Jan 30, 2002 as substantially equivalent to K992553 (Dormer Laboratories, Inc., 2000) after a 75-day review. Its family tree reaches back 2 generations to 1981.

Decided: Jan 30, 2002
Review: 75 days
Class: Class I
Product code: KXF
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K811365 (1981). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK811365 Hill Top ChamberHill Top Research, Inc. · 1981
1 generation backK992553 IQ ChambersDormer Laboratories, Inc. · 2000
This deviceK013820 Finn Chamber (R)Epitest Ltd. OY · 2002

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K811365	Hill Top Chamber	Hill Top Research, Inc.	1981	—
−1	K992553	IQ Chambers	Dormer Laboratories, Inc.	2000	—
0 (this device)	K013820	Finn Chamber (R)	Epitest Ltd. OY	2002	—

FIG. 1 — Lineage of K013820, 1981–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K992553	IQ Chambers Summary page 5 …egulatory and Clinical Affairs Date’ November 15, 2001 Device Name: Finn Chamber® Classification Name: Allergen and Vaccine Delivery System Predicate Device: IQ Chamber (K992553) (Dormer Laboratories, Inc.) Description: Finn Chamber® is an aluminum holding device to place allergens and allergen mixes in c…	Dormer Laboratories, Inc.	2000	—

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 21 years and passes through 3 companies; a new generation was cleared every 18.6 years on median.
None of the 2 ancestors has a recall.

How does its category compare?

All KXF devices

KXF Applicator, Absorbent Tipped, Non-Sterile: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KXF

1in 2012

2007high 1 (2011) · low 0 (2007)2026

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

2007high 134 (2021) · low 5 (2024)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	MAUDE reports
2007	0	—	11
2008	0	—	13
2009	0	—	7
2010	0	—	15
2011	1	—	42
2012	1	—	37
2013	0	—	34
2014	0	—	14
2015	0	—	6
2016	0	—	11
2017	0	—	18
2018	0	—	9
2019	0	—	10
2020	0	—	64
2021	0	—	134
2022	0	—	13
2023	0	—	9
2024	0	—	5
2025	0	—	5
2026	0	—	—

What is it indicated for?

Finn Chamber® is an aluminum holding device to place allergens and allergen mixes in contact with the surface of skin during allergen patch testing.

This product is intended for use by or under the supervision of a physician in the testing of individuals suspected of having allergies. It is not intended for over-the-counter use.

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/K013820 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013820: Finn Chamber (R).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013820

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026