Verathon, Inc.
FDA Regulatory Profile
Verathon, Inc. has 14 FDA recalls (4 Class I), 7 inspections, 5 510(k) clearances and 0 compliance actions on record.
- Latest recall
- Z-2021-2024 · Class II · Apr 29, 2024
- Latest inspection
- Feb 8, 2019 · NAI
- Latest 510(k)
- Sep 15, 2017
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 14 (4 Class I) | Oct 23, 2026 | Not stated | Current |
|---|
| 510(k) clearances | 5 | Oct 4, 2026 | Not stated | Current |
|---|
| Inspections | 7 | Oct 25, 2026 | Not stated | Current |
|---|
| Compliance actions | 0 | Oct 23, 2026 | Not stated | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2021-2024 | Class II | Brand Name: GlideScope Core 15-inch Monitor Model/Catalog Number: 0570-0404 Product Description… | Apr 29, 2024 |
| Z-2022-2024 | Class II | Brand Name: GlideScope Core 15-inch FHD Model/Catalog Number: 0570-0437 Software Version: Core 15… | Apr 29, 2024 |
| Z-2172-2021 | Class III | GlideScope Go Monitors | Jul 1, 2021 |
| Z-0531-2021 | Class II | BladderScan Prime Plus Probe REF 0570-0395 - Product Usage: intended to be used for measuring the… | Sep 29, 2020 |
| Z-2476-2020 | Class I | GlideScope Core OneTouch Smart Cable, REF: 0800 0601, an accessory to the GlideScope Video… | Jun 5, 2020 |
| Z-1471-2020 | Class II | GlideScope Video Laryngoscope, Operations & Maintenance Manual, 0900-4940 REV 03 | Mar 31, 2019 |
| Z-1852-2017 | Class II | It is recommended for patients with weight/size between 4-22 lbs (1.8-10 kg). Part Number… | Mar 3, 2017 |
| Z-1035-2016 | Class I | GlideScope Titanium Single-Use Video Laryngoscope. It is a single-use video laryngoscope system… | Jan 29, 2016 |
| Z-0420-2016 | Class II | GlideScope Video Laryngoscope (GVL), Part Number GVL 3 - 0574-0007; GVL 4 - 0574-0001; GVL 5… | Nov 30, 2015 |
| Z-1091-2016 | Class II | BladderScan BVI 9600, Model Numbers: 0270-0451, 0270-0452, 0270-0754, and U270-0451. AortaScan… | Nov 30, 2015 |
| Z-0421-2016 | Class II | GlideScope AVL Video Laryngoscope (AVL), Part Number AVL 3- 0574-0115; AVL 4-0574-0116, AVL 5… | Nov 30, 2015 |
| Z-0811-2016 | Class II | GlideScope Video Laryngoscope Reusable Blades (GVL 3, 4, 5 and AVL 2, 3, 4, 5). GVL: The… | Apr 13, 2015 |
| Z-1558-2013 | Class I | GlideScope Video Laryngoscope (GVL) 3, 4, 5 and GlideScope (AVL) 2, 3, 4 and 5 reusable blades… | May 8, 2013 |
| Z-0478-2013 | Class I | The GlideScope Video Laryngoscope (GVL) is a video laryngoscope that incorporates a high-resolution… | Oct 25, 2012 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Feb 8, 2019 | Bothell, WA | Devices | No Action Indicated (NAI) | 3022472 |
| Nov 3, 2016 | Bothell, WA | Devices | No Action Indicated (NAI) | 3022472 |
| Aug 3, 2015 | Bothell, WA | Devices | Voluntary Action Indicated (VAI) | 3022472 |
| Jul 23, 2014 | Bothell, WA | Devices | Voluntary Action Indicated (VAI) | 3022472 |
| Feb 7, 2013 | Bothell, WA | Devices | Voluntary Action Indicated (VAI) | 3022472 |
| Jun 4, 2010 | Bothell, WA | Devices | Voluntary Action Indicated (VAI) | 3022472 |
| Jul 10, 2009 | Bothell, WA | Devices | No Action Indicated (NAI) | 3022472 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K172356 | BladderScan Prime PLUS System | Sep 15, 2017 |
| K153101 | BladderScan Prime System | Nov 19, 2015 |
| K090214 | VERATHON INC. BLADDERSCAN BVM 9500 ULTRASOUND | Mar 13, 2009 |
| K082456 | VERATHON INC. BLADDERSCAN ULTRASOUND SYSTEM, MODEL BVI 9600 | Dec 1, 2008 |
| K071217 | BLADDERSCAN BVI 9400 ULTRASOUND | May 17, 2007 |