510(k) Report

510(k) · Cleared

Cleared

MR Tested Fiber Optic Short Laryngoscope Handle, Model 310002

K041852510(k) TraditionalCleared Nov 15, 2004130-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 Nov 15, 2004 after a 130-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.

Decided
Nov 15, 2004
Review
130 days
Class
Class I
Product code
CCW
Recalls
None
Predicates
0

5 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2006: 2 descendants cleared2012: 1 descendant cleared2014: 1 descendant cleared200020052010201520202025
  1. This deviceK041852 MR Tested Fiber Optic Short Laryngoscope Handle, Model 310002Minrad, Inc. · 2004
  2. Descendant · cites it directly · 2 of its ownK062523 Tru-MR Laryngoscope SetTruphatek International, Ltd. · 2006 · Recalled
  3. Descendant · 2 generations on · 0 of its ownK140951 Yeescope LaryngoscopesYeescope Pty., Ltd. · 2014
  4. Descendant · 2 generations on · 0 of its ownK121378 Airtraq SP Airtraq AvantProdol Meditec, Ltd. · 2012
  5. Descendant · cites it directly · 0 of its ownK063477 Novamed Mri Conditional Laryngoscope SetNovamed, LLC · 2007
  6. Descendant · cites it directly · 0 of its ownK062230 MR Fiber Optic Intubating Laryngoscope Handle, Short, Model 310002Minrad, Inc. · 2006

Most influential descendants

Showing 5 of 5 · See all
  • K062523Tru-MR Laryngoscope SetTruphatek International, Ltd. · 2006 · cites it directly2descendants
  • K140951Yeescope LaryngoscopesYeescope Pty., Ltd. · 2014 · 2 generations on0descendants
  • K121378Airtraq SP Airtraq AvantProdol Meditec, Ltd. · 2012 · 2 generations on0descendants
  • K063477Novamed Mri Conditional Laryngoscope SetNovamed, LLC · 2007 · cites it directly0descendants
  • K062230MR Fiber Optic Intubating Laryngoscope Handle, Short, Model 310002Minrad, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K041852MR Tested Fiber Optic Short Laryngoscope Handle, Model 310002Minrad, Inc.2004—
+1K062523Tru-MR Laryngoscope SetTruphatek International, Ltd.20061
+2K140951Yeescope LaryngoscopesYeescope Pty., Ltd.2014—
+2K121378Airtraq SP Airtraq AvantProdol Meditec, Ltd.2012—
+1K063477Novamed Mri Conditional Laryngoscope SetNovamed, LLC2007—
+1K062230MR Fiber Optic Intubating Laryngoscope Handle, Short, Model 310002Minrad, Inc.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200620
200710
201210
201410
FIG. 1 — Lineage of K041852, 2004–2014Source: 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 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (5)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K062523Tru-MR Laryngoscope SetTruphatek International, Ltd.20062
K063477Novamed Mri Conditional Laryngoscope SetNovamed, LLC20070
K062230MR Fiber Optic Intubating Laryngoscope Handle, Short, Model 310002Minrad, Inc.20060

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, K062523 (Truphatek International, Ltd., 2006) has gone furthest, with 2 descendants of its own.

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 MR Tested Fiber Optic Short Laryngoscope Handle ("MINRAD INC. MR Tested Fiber Optic Laryngoscepe Handle") 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 1.5 Tesla static magnetic field.

Indications for use as stated in the FDA 510(k) statement.

Cite this page

510(k) Report. “K041852: MR Tested Fiber Optic Short Laryngoscope Handle, Model 310002.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041852

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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