510(k) Report

510(k) · Cleared

Cleared

Hill Top Chamber

K811365510(k) TraditionalCleared Aug 20, 198198-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

Hill Top Research, Inc. · KXF Applicator, Absorbent Tipped, Non-Sterile

Cleared on Aug 20, 1981 after a 98-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Aug 20, 1981
Review
98 days
Class
Class I
Product code
KXF
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2000: 1 descendant cleared2002: 1 descendant cleared19801990200020102020
  1. This deviceK811365 Hill Top ChamberHill Top Research, Inc. · 1981
  2. Descendant · cites it directly · 1 of its ownK992553 IQ ChambersDormer Laboratories, Inc. · 2000
  3. Descendant · 2 generations on · 0 of its ownK013820 Finn Chamber (R)Epitest Ltd. OY · 2002

Most influential descendants

Showing 2 of 2 · See all
  • K992553IQ ChambersDormer Laboratories, Inc. · 2000 · cites it directly1descendant
  • K013820Finn Chamber (R)Epitest Ltd. OY · 2002 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K811365Hill Top ChamberHill Top Research, Inc.1981—
+1K992553IQ ChambersDormer Laboratories, Inc.2000—
+2K013820Finn Chamber (R)Epitest Ltd. OY2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
200210
FIG. 1 — Lineage of K811365, 1981–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K992553IQ ChambersDormer Laboratories, Inc.20001

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?

  • Of its descendants, K992553 (Dormer Laboratories, Inc., 2000) has gone furthest, with 1 descendant of its own.

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

2011: 12012: 1
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

2007: 112008: 132009: 72010: 152011: 422012: 372013: 342014: 142015: 62016: 112017: 182018: 92019: 102020: 642021: 1342022: 132023: 92024: 52025: 5
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—011
20080—013
20090—07
20100—015
20111—042
20121—037
20130—034
20140—014
20150—06
20160—011
20170—018
20180—09
20190—010
20200—064
20210—0134
20220—013
20230—09
20240—05
20250—05
20260—0—

Recent decisions in KXF

The KXF category page

  • K123184Finn Chambers AquaSmartpractice · 2012
  • K103409Allergeaze R ClearSmartpractice · 2011
  • K063160Allergeaze Patch Test ChambersSmartpractice · 2006
  • K013820Finn Chamber (R)Epitest Ltd. OY · 2002
  • K992553IQ ChambersDormer Laboratories, Inc. · 2000

https://510kreport.com/device/K811365 · printed Nov 6, 2026

Cite this page

510(k) Report. “K811365: Hill Top Chamber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K811365

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026