510(k) · Cleared

Cleared

X-Ray Guaze Sponges

K820106510(k) TraditionalCleared Feb 12, 198228-day reviewClass U

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

Stan-Pak Ent. · EFQ Gauze/Sponge, Internal

Cleared on Feb 12, 1982 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 727 later devices descend from it.

Decided: Feb 12, 1982
Review: 28 days
Class: Class U
Product code: EFQ
Recalls: None
Predicates: 0

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

This deviceK820106 X-Ray Guaze SpongesStan-Pak Ent. · 1982
Descendant · cites it directly · 726 of its ownK962791 New Star Model 130 6-Watt ND: Yag Laser SystemNew Star Lasers, Inc. · 1997
Descendant · 2 generations on · 668 of its ownK014035 Cooltouch and Cooltouch-II ND:Yag Laser SystemsCooltouch Corp. · 2002
Descendant · 3 generations on · 665 of its ownK022226 Altus Medical Family of Coolglide Lasers, Models Coolglide I…Altus Medical, Inc. · 2002
Descendant · 2 generations on · 575 of its ownK022817 Cooltouch ND:Yag Laser System, Model Cooltouch, Cooltouch-II ND:Yag…Icn Pharmaceuticals, Inc. · 2002
Descendant · 3 generations on · 520 of its ownK022466 Profile 1320 Laser SystemSciton, Inc · 2002

Showing 5 of 727 descendants. See all descendants

Descendants cleared per year

1997high 84 (2025) · low 0 (1998)2026

Most influential descendants

Showing 5 of 727 · See all

K962791New Star Model 130 6-Watt ND: Yag Laser SystemNew Star Lasers, Inc. · 1997 · cites it directly726descendants
K014035Cooltouch and Cooltouch-II ND:Yag Laser SystemsCooltouch Corp. · 2002 · 2 generations on668descendants
K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Altus Medical, Inc. · 2002 · 3 generations on665descendants
K022817Cooltouch ND:Yag Laser System, Model Cooltouch, Cooltouch-II ND:Yag Laser System, Model…Icn Pharmaceuticals, Inc. · 2002 · 2 generations on575descendants
K022466Profile 1320 Laser SystemSciton, Inc · 2002 · 3 generations on520descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K820106	X-Ray Guaze Sponges	Stan-Pak Ent.	1982	—
+1	K962791	New Star Model 130 6-Watt ND: Yag Laser System	New Star Lasers, Inc.	1997	—
+2	K014035	Cooltouch and Cooltouch-II ND:Yag Laser Systems	Cooltouch Corp.	2002	—
+3	K022226	Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II…	Altus Medical, Inc.	2002	—
+2	K022817	Cooltouch ND:Yag Laser System, Model Cooltouch, Cooltouch-II ND:Yag Laser…	Icn Pharmaceuticals, Inc.	2002	—
+3	K022466	Profile 1320 Laser System	Sciton, Inc	2002	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
2002	4	0
2003	7	0
2004	7	0
2005	5	0
2006	5	0
2007	16	0
2008	24	0
2009	15	0
2010	19	0
2011	24	0
2012	21	0
2013	26	0
2014	30	0
2015	27	0
2016	37	0
2017	33	0
2018	31	0
2019	23	0
2020	42	0
2021	32	0
2022	54	0
2023	42	0
2024	71	0
2025	84	0
2026	47	0

FIG. 1 — Lineage of K820106, 1982–2026Source: 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 EFQ? 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? (727)

See all 727

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

Number	Device	Applicant	Decided	Descendants
K962791	New Star Model 130 6-Watt ND: Yag Laser System	New Star Lasers, Inc.	1997	726

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, K962791 (New Star Lasers, Inc., 1997) has gone furthest, with 726 descendants of its own.

How does its category compare?

All EFQ devices

EFQ Gauze/Sponge, Internal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EFQ

FDA has decided no EFQ device since 2007.

Median 510(k) review, days · EFQ

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

Recalls per year · EFQ

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 · EFQ

51in 2025

2007high 53 (2016) · low 0 (2008)2025

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

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	4
2008	—	0	0
2009	—	0	4
2010	—	0	9
2011	—	0	6
2012	—	0	9
2013	—	0	8
2014	—	0	11
2015	—	0	27
2016	—	0	53
2017	—	0	8
2018	—	0	7
2019	—	0	5
2020	—	1	8
2021	—	0	6
2022	—	1	6
2023	—	0	10
2024	—	0	8
2025	—	0	51
2026	—	3	—

https://510kreport.com/device/K820106 · printed Nov 6, 2026

Cite this page

510(k) Report. “K820106: X-Ray Guaze Sponges.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K820106

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