510(k) · Cleared

Cleared

Flotation Pad for Operating Table

K801694510(k) TraditionalCleared Aug 27, 198035-day reviewClass I21 CFR 880.6450

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

Action Products, Inc. · FMP Protector, Skin Pressure

Cleared on Aug 27, 1980 after a 35-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 of the 8 devices in its family, counting itself, have a Class I recall. 7 later devices descend from it.

Decided: Aug 27, 1980
Review: 35 days
Class: Class I
Product code: FMP
Recalls: None
Predicates: 0

7 later devices descend from it, 1 citing it directly. 5 of the 8 devices in this family, counting this one, have a Class I recall.

This deviceK801694 Flotation Pad for Operating TableAction Products, Inc. · 1980
Descendant · cites it directly · 6 of its ownK021077 Mega 2000 Soft Patient Return Electrode PadMegadyne Medical Products, Inc. · 2002 · Recalled (Class I)
Descendant · 2 generations on · 5 of its ownK031285 Mega 2000 Soft Dual Cord Patient Return Electrode PadMegadyne Medical Products, Inc. · 2003 · Recalled (Class I)
Descendant · 2 generations on · 4 of its ownK080741 Mega Soft Reusable Patient Return ElectrodeMegadyne Medical Products, Inc. · 2008 · Recalled (Class I)
Descendant · 3 generations on · 3 of its ownK133726 Mega Soft Universal Patient Return ElectrodeMegadyne Medical Products, Inc. · 2014 · Recalled (Class I)
Descendant · 4 generations on · 0 of its ownK233644 Megadyne Patient Return Electrode Pad - Universal Dual (model 0846)…Megadyne Medical Products, Inc. · 2024 · Recalled (Class I)

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2002high 1 (2002) · low 0 (2004)2026

Class I recalls in this family

K021077 Mega 2000 Soft Patient Return Electrode Padcites it directly · 2002
K031285 Mega 2000 Soft Dual Cord Patient Return…2 generations on · 2003
K080741 Mega Soft Reusable Patient Return Electrode2 generations on · 2008
K133726 Mega Soft Universal Patient Return Electrode3 generations on · 2014

Most influential descendants

Showing 5 of 7 · See all

K021077Mega 2000 Soft Patient Return Electrode PadMegadyne Medical Products, Inc. · 2002 · cites it directly6descendants
K031285Mega 2000 Soft Dual Cord Patient Return Electrode PadMegadyne Medical Products, Inc. · 2003 · 2 generations on5descendants
K080741Mega Soft Reusable Patient Return ElectrodeMegadyne Medical Products, Inc. · 2008 · 2 generations on4descendants
K133726Mega Soft Universal Patient Return ElectrodeMegadyne Medical Products, Inc. · 2014 · 3 generations on3descendants
K233644Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient…Megadyne Medical Products, Inc. · 2024 · 4 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K801694	Flotation Pad for Operating Table	Action Products, Inc.	1980	—
+1	K021077	Mega 2000 Soft Patient Return Electrode Pad	Megadyne Medical Products, Inc.	2002	Class I
+2	K031285	Mega 2000 Soft Dual Cord Patient Return Electrode Pad	Megadyne Medical Products, Inc.	2003	Class I
+2	K080741	Mega Soft Reusable Patient Return Electrode	Megadyne Medical Products, Inc.	2008	Class I
+3	K133726	Mega Soft Universal Patient Return Electrode	Megadyne Medical Products, Inc.	2014	Class I
+4	K233644	Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne…	Megadyne Medical Products, Inc.	2024	Class I

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	1
2003	1	1
2008	1	1
2014	1	1
2020	1	0
2022	1	0
2024	1	1

FIG. 1 — Lineage of K801694, 1980–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

5 devices in this family have a Class I recall. 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

Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (7)

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

Number	Device	Applicant	Decided	Descendants
K021077	Mega 2000 Soft Patient Return Electrode Pad Class I	Megadyne Medical Products, Inc.	2002	6

Has anything in its family been recalled? (5 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K021077Mega 2000 Soft Patient Return Electrode PadMegadyne Medical Products, Inc. · 2002 · Cites it directly · ◆ in the 2002 descendants bar of FIG. 12 Class I recalls
K031285Mega 2000 Soft Dual Cord Patient Return Electrode PadMegadyne Medical Products, Inc. · 2003 · 2 generations on · ◆ in the 2003 descendants bar of FIG. 12 Class I recalls
K080741Mega Soft Reusable Patient Return ElectrodeMegadyne Medical Products, Inc. · 2008 · 2 generations on · ◆ in the 2008 descendants bar of FIG. 13 Class I recalls
K133726Mega Soft Universal Patient Return ElectrodeMegadyne Medical Products, Inc. · 2014 · 3 generations on · ◆ in the 2014 descendants bar of FIG. 15 Class I recalls
K233644Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient Return Electrode Pad -…Megadyne Medical Products, Inc. · 2024 · 4 generations on · ◆ in the 2024 descendants bar of FIG. 13 Class I recalls

What does this lineage say?

Of its descendants, K021077 (Megadyne Medical Products, Inc., 2002) has gone furthest, with 6 descendants of its own.

How does its category compare?

All FMP devices

FMP Protector, Skin Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FMP

1in 2015

2007high 1 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMP

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

Recalls per year · FMP

1in 2015

2007high 1 (2014) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · FMP

35in 2025

2007high 60 (2022) · low 0 (2007)2025

MAUDE reports naming product code FMP, 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	0
2008	0	—	0	1
2009	0	—	0	7
2010	0	—	0	2
2011	0	—	0	4
2012	0	—	0	7
2013	0	—	0	2
2014	0	—	1 (1)	26
2015	1	—	1	9
2016	0	—	0	11
2017	0	—	0	2
2018	0	—	0	1
2019	0	—	0	5
2020	0	—	0	3
2021	0	—	0	4
2022	0	—	0	60
2023	0	—	0	15
2024	0	—	0	10
2025	0	—	0	35
2026	0	—	0	—

https://510kreport.com/device/K801694 · printed Nov 4, 2026

Cite this page

510(k) Report. “K801694: Flotation Pad for Operating Table.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K801694

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026