510(k) Report

510(k) · Cleared

Cleared

Rhinomanometer A440 Digital

K844230510(k) TraditionalCleared Nov 27, 198426-day reviewClass II21 CFR 868.1800

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

Center Laboratories, Inc. · BXQ Rhinoanemometer (Measurement Of Nasal Decongestion)

Cleared on Nov 27, 1984 after a 26-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Nov 27, 1984
Review
26 days
Class
Class II
Product code
BXQ
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K844230Source: FDA 510(k) database · 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 BXQ? 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 BXQ device

  1. #1 K221892 Visionairscore 4.4 · 2 generations · no Class I recall
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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?

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.

How does its category compare?

All BXQ devices

BXQ Rhinoanemometer (Measurement Of Nasal Decongestion): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BXQ

1in 2022

2017: 12022: 1
2007high 1 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BXQ

Too few BXQ 510(k)s in any year since 2007 to give a median.

Recalls per year · BXQ

No recall names BXQ since 2007.

Adverse event reports per year · BXQ

No MAUDE report names BXQ since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20171—00
20180—00
20190—00
20200—00
20210—00
20221—00
20230—00
20240—00
20250—00
20260—0—

More from Center Laboratories, Inc.

2 FDA decisions under this applicant name. See the company

  • K954277Astech Peak Flow MeterCenter Laboratories, Inc. · 1996

Recent decisions in BXQ

The BXQ category page

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  • K170071SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM Rhino/PharyngometerSleep Group Solutions · 2017
  • K022311Rhinostream Rhinomanometer ModuleRhino Metrics A/S · 2002
  • K011329Eccovision Acoustic Diagnostic Imaging Acoustic PharyngometerE. Benson Hood Lab, Inc. · 2002
  • K000406Rhinoscan Model SRE2000/ SRE2100 with Acoustic Rhinometry ModuleRhino Metrics A/S · 2000

https://510kreport.com/device/K844230 · printed Nov 6, 2026

Cite this page

510(k) Report. “K844230: Rhinomanometer A440 Digital.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K844230

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