510(k) Report

510(k) · Cleared

Cleared

ScanNav Anatomy Peripheral Nerve Block

K232787510(k) SpecialCleared Oct 6, 202325-day reviewClass II21 CFR 868.1980

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

Intelligent Ultrasound Limited · QRG Ultrasound Guided Nerve Block Assist

Cleared on Oct 6, 2023 as substantially equivalent to DEN220024 (Intelligent Ultrasound Limited, 2022) after a 25-day review. Its family tree reaches back 1 generation to 2022. 1 later device descends from it.

Decided
Oct 6, 2023
Review
25 days
Class
Class II
Product code
QRG
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to DEN220024 (2022). 1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2025: 1 descendant clearedDEN220024 · ScanNav Anatomy Peripheral Nerve Block · Intelligent Ultrasound Limited · 20222020202220242026
Descendants, by generation 1 generation forward: 1 descendant DEN220024 · ScanNav Anatomy Peripheral Nerve Block · Intelligent Ultrasound Limited · 20220
  1. Root · 1 generation backDEN220024 ScanNav Anatomy Peripheral Nerve BlockIntelligent Ultrasound Limited · 2022
  2. This deviceK232787 ScanNav Anatomy Peripheral Nerve BlockIntelligent Ultrasound Limited · 2023
  3. Descendant · cites it directly · 0 of its ownK250818 NervebloxSmart Alfa Teknoloji San. Ve Tic. A.S. · 2025

Most influential descendants

Showing 1 of 1 · See all
  • K250818NervebloxSmart Alfa Teknoloji San. Ve Tic. A.S. · 2025 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1DEN220024ScanNav Anatomy Peripheral Nerve BlockIntelligent Ultrasound Limited2022—
0 (this device)K232787ScanNav Anatomy Peripheral Nerve BlockIntelligent Ultrasound Limited2023—
+1K250818NervebloxSmart Alfa Teknoloji San. Ve Tic. A.S.2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202510
FIG. 1 — Lineage of K232787, 2022–2025Source: 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), 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 QRG? 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 QRG device

  1. #1 K250818 Nervebloxscore 10.1 · 2 generations · no Class I recall
Get a 510(k) Report

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.

TypeNumberDeviceApplicantDecidedRecalls
*DEN220024ScanNav Anatomy Peripheral Nerve Block
Summary page 5
…ication: Class II Regulation Number: 21 CFR 868.1980 Product Code: QRG Predicate Device details: Device Trade Name: ScanNav Anatomy Peripheral Nerve Block Predicate #: DEN220024 Product code: QRG 510(k) Summary Page 1 of 6…
Intelligent Ultrasound Limited2022—

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K250818NervebloxSmart Alfa Teknoloji San. Ve Tic. A.S.20250

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?

  • Its one ancestor has no recall.
  • Of its descendants, K250818 (Smart Alfa Teknoloji San. Ve Tic. A.S., 2025) has gone furthest, with 0 descendants of its own.

How does its category compare?

All QRG devices

QRG Ultrasound Guided Nerve Block Assist: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · QRG

1in 2025

2022: 12023: 12025: 1
2007high 1 (2022) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QRG

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

Recalls per year · QRG

No recall names QRG since 2007.

Adverse event reports per year · QRG

No MAUDE report names QRG 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
20170—00
20180—00
20190—00
20200—00
20210—00
20221—00
20231—00
20240—00
20251—00
20260—0—

What is it indicated for?

ScanNav Anatomy Peripheral Nerve Block is indicated to assist qualified healthcare professionals to identify and label the below mentioned anatomy in live ultrasound images in preparation for ultrasound guided regional anesthesia prior to needle insertion for patients 18 years of age or older. The highlighting of structures in the following anatomical regions is supported: • Axillary level brachial plexus • Erector spinae plane • Interscalene level…

Read the full statement (118 words)

ScanNav Anatomy Peripheral Nerve Block is indicated to assist qualified healthcare professionals to identify and label the

below mentioned anatomy in live ultrasound images in preparation for ultrasound guided regional anesthesia prior to

needle insertion for patients 18 years of age or older.

The highlighting of structures in the following anatomical regions is supported:

• Axillary level brachial plexus

• Erector spinae plane

• Interscalene level brachial plexus

• Popliteal level sciatic nerve

• Rectus sheath plane

• Sub-sartorial femoral triangle / Adductor canal

• Superior trunk of brachial plexus

• Supraclavicular level brachial plexus

• Longitudinal suprainguinal fascia iliaca plane

• Femoral block

ScanNav Anatomy Peripheral Nerve Block is an accessory to compatible general-purpose diagnostic ultrasound systems.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K232787: ScanNav Anatomy Peripheral Nerve Block.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232787

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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