510(k) · Cleared

Cleared

Lina Powerblade, Model 5005,5005-E,5005-C,5005-150,5000-C-150,5005-E-C-150,5005-420,5005-C-420,5005-E-420,5005-E-C-420,

K063025510(k) TraditionalCleared Dec 1, 200660-day reviewClass II21 CFR 878.4400

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

Lina Medical Aps · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Dec 1, 2006 after a 60-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.

Decided: Dec 1, 2006
Review: 60 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK063025 Lina Powerblade, Model…Lina Medical Aps · 2006
Descendant · cites it directly · 1 of its ownK132837 Lina Powerblade PlusLina Medical Aps · 2013
Descendant · 2 generations on · 0 of its ownK142757 LiNA PowerBlade Plus HCLina Medical Aps · 2014

Most influential descendants

Showing 2 of 2 · See all

K132837Lina Powerblade PlusLina Medical Aps · 2013 · cites it directly1descendant
K142757LiNA PowerBlade Plus HCLina Medical Aps · 2014 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K063025	Lina Powerblade, Model…	Lina Medical Aps	2006	—
+1	K132837	Lina Powerblade Plus	Lina Medical Aps	2013	—
+2	K142757	LiNA PowerBlade Plus HC	Lina Medical Aps	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0
2014	1	0

FIG. 1 — Lineage of K063025, 2006–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 GEI? 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 GEI device

#1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 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?

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

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K132837	Lina Powerblade Plus	Lina Medical Aps	2013	1

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, K132837 (Lina Medical Aps, 2013) has gone furthest, with 1 descendant of its own.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEI

52in 2025

2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007high 183 (2026) · low 51 (2007)2026

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

Recalls per year · GEI

4in 2025

2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, 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	50	51	21	2,795
2008	61	71	19	2,556
2009	42	130	27	3,591
2010	46	109	51	3,377
2011	35	135	32	4,463
2012	39	133	30	5,216
2013	48	136	13	4,897
2014	49	103	3	4,908
2015	47	123	4	4,936
2016	64	108	3	5,616
2017	52	72	2	6,073
2018	47	93	6	6,545
2019	48	93	5	7,067
2020	59	105	1	6,490
2021	46	146	6	6,354
2022	55	150	49	6,103
2023	65	104	27 (4)	7,176
2024	59	125	22 (10)	7,897
2025	52	113	4	7,592
2026	43	183	8	—

What is it indicated for?

The LiNA PowerBlade is intended for use in open and laparoscopic surgery where grasping, coagulating, and transecting is indicated.

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

https://510kreport.com/device/K063025 · printed Nov 4, 2026

Cite this page

510(k) Report. “K063025: Lina Powerblade, Model 5005,5005-E,5005-C,5005-150,5000-C-150,5005-E-C-150,5005-420,5005-C-420,5005-E-420,5005-E-C-420,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063025

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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