510(k) · Cleared

Cleared

Telescoping Penevac

K954088510(k) TraditionalCleared Sep 22, 199522-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

I.C Medical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Sep 22, 1995 after a 22-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 24 later devices descend from it.

Decided: Sep 22, 1995
Review: 22 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 0

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

This deviceK954088 Telescoping PenevacI.C Medical, Inc. · 1995
Descendant · cites it directly · 20 of its ownK103375 Plumepen Integrated Smoke Evacuation PencilMedtek Devices, Inc. · 2011
Descendant · 2 generations on · 8 of its ownK120454 Safeair Smoke Pencil,Lna Medical Aps · 2012
Descendant · 3 generations on · 5 of its ownK142538 LiNA SafeAir Smoke PencilLina Medical Aps · 2014
Descendant · 2 generations on · 4 of its ownK182772 Valleylab Smoke Evacuation Rocker Switch Pencil , Valleylab…Covidien · 2018
Descendant · 3 generations on · 4 of its ownK143145 SafeAir Smoke PencilLina Medical Aps · 2014 · Recalled

Showing 5 of 24 descendants. See all descendants

Descendants cleared per year

1996high 3 (2014) · low 0 (1997)2026

Most influential descendants

Showing 5 of 24 · See all

K103375Plumepen Integrated Smoke Evacuation PencilMedtek Devices, Inc. · 2011 · cites it directly20descendants
K120454Safeair Smoke Pencil,Lna Medical Aps · 2012 · 2 generations on8descendants
K142538LiNA SafeAir Smoke PencilLina Medical Aps · 2014 · 3 generations on5descendants
K182772Valleylab Smoke Evacuation Rocker Switch Pencil , Valleylab Telescoping Smoke Evacuation…Covidien · 2018 · 2 generations on4descendants
K143145SafeAir Smoke PencilLina Medical Aps · 2014 · 3 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K954088	Telescoping Penevac	I.C Medical, Inc.	1995	—
+1	K103375	Plumepen Integrated Smoke Evacuation Pencil	Medtek Devices, Inc.	2011	—
+2	K120454	Safeair Smoke Pencil,	Lna Medical Aps	2012	—
+3	K142538	LiNA SafeAir Smoke Pencil	Lina Medical Aps	2014	—
+2	K182772	Valleylab Smoke Evacuation Rocker Switch Pencil , Valleylab Telescoping Smoke…	Covidien	2018	—
+3	K143145	SafeAir Smoke Pencil	Lina Medical Aps	2014	8

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
2011	2	0
2012	1	0
2014	3	0
2015	1	0
2016	3	0
2018	2	0
2020	2	0
2022	2	0
2023	2	0
2024	1	0
2025	2	0
2026	2	0

FIG. 1 — Lineage of K954088, 1995–2026Source: 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.

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

What descends from it? (24)

See all 24

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

Number	Device	Applicant	Decided	Descendants
K103375	Plumepen Integrated Smoke Evacuation Pencil	Medtek Devices, Inc.	2011	20
K955020	Penevac Abc Handpiece	I.C Medical, Inc.	1996	1
K160160	Non-Telescopic PenEvac	I.C Medical, Inc.	2016	0

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, K103375 (Medtek Devices, Inc., 2011) has gone furthest, with 20 descendants 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	—

https://510kreport.com/device/K954088 · printed Nov 5, 2026

Cite this page

510(k) Report. “K954088: Telescoping Penevac.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K954088

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Record history

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