510(k) · Cleared

Cleared

SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM Rhino/Pharyngometer

K170071510(k) TraditionalCleared Nov 9, 2017304-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

Sleep Group Solutions · BXQ Rhinoanemometer (Measurement Of Nasal Decongestion)

Cleared on Nov 9, 2017 as substantially equivalent to K011329 (E. Benson Hood Lab, Inc., 2002) and 1 other predicate after a 304-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.

Decided: Nov 9, 2017
Review: 304 days
Class: Class II
Product code: BXQ
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K921452 (1993). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK921452 Acoustic RhinometerHood Laboratories · 1993
This deviceK170071 SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS…Sleep Group Solutions · 2017
Descendant · cites it directly · 0 of its ownK221892 VisionairPacificmd Biotech, LLC · 2022

Most influential descendants

Showing 1 of 1 · See all

K221892VisionairPacificmd Biotech, LLC · 2022 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K921452	Acoustic Rhinometer	Hood Laboratories	1993	—
0 (this device)	K170071	SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM…	Sleep Group Solutions	2017	—
+1	K221892	Visionair	Pacificmd Biotech, LLC	2022	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2022	1	0

FIG. 1 — Lineage of K170071, 1993–2022Source: 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 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 K221892 Visionairscore 4.4 · 2 generations · no Class I recall

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What was it cleared against? (2)

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
*	K011329	Eccovision Acoustic Diagnostic Imaging Acoustic Pharyngometer Summary page 4 …Class II Panel: Anesthesiology Product Code: BXQ Predicate Device: K011329 – SGS Eccovision Rhinometer and K921452 – SGS Eccovision Pharyngometer…	E. Benson Hood Lab, Inc.	2002	—
*	K921452	Acoustic Rhinometer Summary page 4 …hesiology Product Code: BXQ Predicate Device: K011329 – SGS Eccovision Rhinometer and K921452 – SGS Eccovision Pharyngometer (Submitter’s previously cleared devices) Description…	Hood Laboratories	1993	—

Also cleared against K011329: 1 other device →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K221892	Visionair	Pacificmd Biotech, LLC	2022	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?

None of the 2 ancestors has a recall.
Of its descendants, K221892 (Pacificmd Biotech, LLC, 2022) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K011329.

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. 2017, this device’s year, is highlighted.

FDA decisions per year · BXQ

1in 2022

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

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	1	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	1	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

To measure the upper respiratory airway by means of acoustic reflection

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K170071 · printed Nov 5, 2026

Cite this page

510(k) Report. “K170071: SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM Rhino/Pharyngometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K170071

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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