510(k) Report

510(k) · Cleared

Cleared

MR Fiber Optic Intubating Laryngoscope Handle, Standard, Model 310001

K062231510(k) SpecialCleared Aug 31, 200629-day reviewClass I21 CFR 868.5540

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

Minrad, Inc. · CCW Laryngoscope, Rigid

Cleared on Aug 31, 2006 as substantially equivalent to K970619 (Wilson Greatbatch Technologies, Inc., 1997) after a 29-day review. Its family tree reaches back 1 generation to 1997.

Decided
Aug 31, 2006
Review
29 days
Class
Class I
Product code
CCW
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K970619 (1997). No later device cites it as a predicate yet.

K970619 · Greatbatch Scientific Mri Compatible Fiber Optic Laryngoscope Handle · Wilson Greatbatch Technologies, Inc. · 19971996199820002002200420062008
K970619 · Greatbatch Scientific Mri Compatible Fiber Optic Laryngoscope Handle · Wilson Greatbatch Technologies, Inc. · 19970
  1. Root · 1 generation backK970619 Greatbatch Scientific Mri Compatible Fiber Optic Laryngoscope HandleWilson Greatbatch Technologies, Inc. · 1997
  2. This deviceK062231 MR Fiber Optic Intubating Laryngoscope Handle, Standard, Model 310001Minrad, Inc. · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K970619Greatbatch Scientific Mri Compatible Fiber Optic Laryngoscope HandleWilson Greatbatch Technologies, Inc.1997—
0 (this device)K062231MR Fiber Optic Intubating Laryngoscope Handle, Standard, Model 310001Minrad, Inc.2006—
FIG. 1 — Lineage of K062231, 1997–2006Source: 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 CCW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (3)

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
*K970619Greatbatch Scientific Mri Compatible Fiber Optic Laryngoscope Handle
Summary page 1
…4. Classification Name Laryngoscope, Rigid (21 CFR 868.5540, Product Code CCW) 5. Predicate Devices MINRAD INC. MR Fiber Optic Laryngoscope Handle (K970619) Laryngoscope, Welch Allyn Laryngoscope, Sun Med 6. Intended Use The MR Fiber Optic Intubating Laryngoscop…
Wilson Greatbatch Technologies, Inc.1997—
*—Laryngoscope, Welch Allyn
Named without a submission number
—
*—Laryngoscope, Sun Med
Named without a submission number
—

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.

What does this lineage say?

  • Its one ancestor has no recall.

How does its category compare?

All CCW devices

CCW Laryngoscope, Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CCW

1in 2019

2007: 12012: 12014: 12017: 12019: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CCW

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

Recalls per year · CCW

4in 2023

2007: 22010: 12011: 22012: 1, 1 Class I2013: 12014: 12015: 32016: 1, 1 Class I2017: 12019: 3, 1 Class I2023: 4, 1 Class I
2007high 4 (2023) · low 0 (2008)2026

Class I (4 since 2007) Class II/III not classified

Adverse event reports per year · CCW

1,569in 2025

2007: 62008: 142009: 172010: 262011: 212012: 712013: 3362014: 2022015: 3012016: 8252017: 4142018: 3832019: 3612020: 4962021: 4372022: 3242023: 3462024: 4732025: 1,569
2007high 1,569 (2025) · low 6 (2007)2025

MAUDE reports naming product code CCW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—26
20080—014
20090—017
20100—126
20110—221
20121—1 (1)71
20130—1336
20141—1202
20150—3301
20160—1 (1)825
20171—1414
20180—0383
20191—3 (1)361
20200—0496
20210—0437
20220—0324
20230—4 (1)346
20240—0473
20250—01,569
20260—0—

What is it indicated for?

The MiR MR Fiber Optic Intubating Laryngoscope Handle, Standard ("MINILAD INC. MR Fiber Optic Intubating Laryngoscope Handle, Standard") is used, together with a Laryngoscope blade, to facilitate and aid in tracheal intubation in a Magnetic Resonance Imaging (MRI) or an interventional Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.

Indications for use as stated in the FDA summary.

More from Minrad, Inc.

14 FDA decisions under this applicant name. See the company

  • K072255Minrad Inc. Nasal Scavenging CircuitMinrad, Inc. · 2007
  • K071814Light Sabre Spinal Access DeviceMinrad, Inc. · 2007
  • K062230MR Fiber Optic Intubating Laryngoscope Handle, Short, Model 310002Minrad, Inc. · 2006
  • K041852MR Tested Fiber Optic Short Laryngoscope Handle, Model 310002Minrad, Inc. · 2004
  • K041846Sabresource DrapeMinrad, Inc. · 2004

Recent decisions in CCW

The CCW category page

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  • K163412Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL)Girgis Scope, LLC · 2017
  • K140951Yeescope LaryngoscopesYeescope Pty., Ltd. · 2014
  • K121378Airtraq SP Airtraq AvantProdol Meditec, Ltd. · 2012
  • K063477Novamed Mri Conditional Laryngoscope SetNovamed, LLC · 2007

https://510kreport.com/device/K062231 · printed Nov 5, 2026

Cite this page

510(k) Report. “K062231: MR Fiber Optic Intubating Laryngoscope Handle, Standard, Model 310001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062231

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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