510(k) Report

510(k) · Cleared

Cleared

Acoustic Rhinometer

K921452510(k) TraditionalCleared Jul 8, 1993469-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

Hood Laboratories · BXQ Rhinoanemometer (Measurement Of Nasal Decongestion)

Cleared on Jul 8, 1993 after a 469-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.

Decided
Jul 8, 1993
Review
469 days
Class
Class II
Product code
BXQ
Recalls
None
Predicates
0

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

Descendants, by year cleared 2017: 1 descendant cleared2022: 1 descendant cleared1990200020102020
  1. This deviceK921452 Acoustic RhinometerHood Laboratories · 1993
  2. Descendant · cites it directly · 1 of its ownK170071 SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS…Sleep Group Solutions · 2017
  3. Descendant · 2 generations on · 0 of its ownK221892 VisionairPacificmd Biotech, LLC · 2022

Most influential descendants

Showing 2 of 2 · See all
  • K170071SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM…Sleep Group Solutions · 2017 · cites it directly1descendant
  • K221892VisionairPacificmd Biotech, LLC · 2022 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K921452Acoustic RhinometerHood Laboratories1993—
+1K170071SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM…Sleep Group Solutions2017—
+2K221892VisionairPacificmd Biotech, LLC2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
202210
FIG. 1 — Lineage of K921452, 1993–2022Source: 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 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
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, 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
K170071SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM…Sleep Group Solutions20171

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, K170071 (Sleep Group Solutions, 2017) has gone furthest, with 1 descendant of its own.

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 Hood Laboratories

19 FDA decisions under this applicant name. See the company

  • K920994Hood Nasal Septal ButtonHood Laboratories · 1992
  • K905703Krupin Eye Valve with DiskHood Laboratories · 19914 recalls
  • K904821Eliachar Modified Esophageal StentHood Laboratories · 1991
  • K897049Gibson Endolymphatic ShuntHood Laboratories · 1990
  • K897059Hood Speaking ValveHood Laboratories · 1990

Recent decisions in BXQ

The BXQ category page

  • K221892VisionairPacificmd Biotech, LLC · 2022
  • 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/K921452 · printed Nov 5, 2026

Cite this page

510(k) Report. “K921452: Acoustic Rhinometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K921452

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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