510(k) · Cleared

Cleared

Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor

K200250510(k) TraditionalCleared Jun 26, 2020144-day reviewClass II21 CFR 878.5070

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

Megadyne Medical Products, Inc. · FYD Apparatus, Exhaust, Surgical

Cleared on Jun 26, 2020 as substantially equivalent to K163659 (I.C Medical, Inc., 2017) after a 144-day review. Its family tree reaches back 2 generations to 1994.

Decided: Jun 26, 2020
Review: 144 days
Class: Class II
Product code: FYD
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K932230 (1994). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK932230 Crystal Vision and AccessoriesI.C Medical, Inc. · 1994
1 generation backK163659 Crystal VisionI.C Medical, Inc. · 2017
This deviceK200250 Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap…Megadyne Medical Products, Inc. · 2020

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K932230	Crystal Vision and Accessories	I.C Medical, Inc.	1994	—
−1	K163659	Crystal Vision	I.C Medical, Inc.	2017	—
0 (this device)	K200250	Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne…	Megadyne Medical Products, Inc.	2020	—

FIG. 1 — Lineage of K200250, 1994–2020Source: 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 FYD? 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 FYD device

#1 K240127 PlumeSafe X5 Smoke Management Systemscore 8.7 · 4 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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.

Type	Number	Device	Applicant	Decided	Recalls
*	K163659	Crystal Vision Summary page 4 …on Name Air-handling apparatus for surgical operating room (21 CFR 878.5070, Product Code FYD) Regulatory Class Class II Predicate Devices Crystal Vision cleared under K163659 on October 30, 2017 Device Description The Megadyne Smoke Evacuator is designed to provide smoke evacuation in open and Laparosc…	I.C Medical, Inc.	2017	—

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?

The line of descent spans 26 years and passes through 2 companies; a new generation was cleared every 23.7 years on median.
None of the 2 ancestors has a recall.

How does its category compare?

All FYD devices

FYD Apparatus, Exhaust, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.

FDA decisions per year · FYD

2in 2024

2007high 3 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FYD

71in 2019

2007high 71 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FYD

3so far in 2026, the most since 2007

2007high 3 (2026) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FYD

15in 2025

2007high 150 (2011) · low 2 (2016)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	3
2008	0	—	0	4
2009	1	—	0	5
2010	0	—	1	39
2011	0	—	0	150
2012	0	—	0	120
2013	0	—	0	142
2014	1	—	0	71
2015	1	—	0	21
2016	0	—	0	2
2017	1	—	0	3
2018	1	—	0	5
2019	3	71	0	11
2020	1	—	0	11
2021	1	—	0	20
2022	1	—	0	46
2023	0	—	0	19
2024	2	—	0	11
2025	0	—	0	15
2026	0	—	3	—

What is it indicated for?

The Megadyne Smoke Evacuator with accessories is intended to remove smoke created in surgical procedures at the surgical site.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K200250 · printed Nov 4, 2026

Cite this page

510(k) Report. “K200250: Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K200250

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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