510(k) · Cleared

Cleared

Sterilization Mats

K103226510(k) TraditionalCleared Feb 18, 2011109-day reviewClass II21 CFR 880.6850

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

STERIS Corporation · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Cleared on Feb 18, 2011 as substantially equivalent to K013003 (Advanced Sterilization Products, 2002) after a 109-day review. Its family tree reaches back 1 generation to 2002. 8 later devices descend from it.

Decided: Feb 18, 2011
Review: 109 days
Class: Class II
Product code: KCT
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K013003 (2002). 8 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK013003 Aptimax Instrument Tray, Instrument Mat and Instrument HolderAdvanced Sterilization Products · 2002
This deviceK103226 Sterilization MatsSTERIS Corporation · 2011
Descendant · cites it directly · 7 of its ownK140494 V-Pro Sterilization Tray/ Sterilization MatSTERIS Corporation · 2014
Descendant · 2 generations on · 6 of its ownK160912 Sterilization TraySTERIS Corporation · 2016
Descendant · 3 generations on · 5 of its ownK172755 PRO-LITE Sterilization TraysSTERIS Corporation · 2018
Descendant · 4 generations on · 3 of its ownK183402 PRO-LITE Sterilization TraySTERIS Corporation · 2019
Descendant · 5 generations on · 2 of its ownK222440 Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE…Steris · 2022

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2014high 2 (2019) · low 0 (2015)2026

Most influential descendants

Showing 5 of 8 · See all

K140494V-Pro Sterilization Tray/ Sterilization MatSTERIS Corporation · 2014 · cites it directly7descendants
K160912Sterilization TraySTERIS Corporation · 2016 · 2 generations on6descendants
K172755PRO-LITE Sterilization TraysSTERIS Corporation · 2018 · 3 generations on5descendants
K183402PRO-LITE Sterilization TraySTERIS Corporation · 2019 · 4 generations on3descendants
K222440Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization TraysSteris · 2022 · 5 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K013003	Aptimax Instrument Tray, Instrument Mat and Instrument Holder	Advanced Sterilization Products	2002	—
0 (this device)	K103226	Sterilization Mats	STERIS Corporation	2011	—
+1	K140494	V-Pro Sterilization Tray/ Sterilization Mat	STERIS Corporation	2014	—
+2	K160912	Sterilization Tray	STERIS Corporation	2016	—
+3	K172755	PRO-LITE Sterilization Trays	STERIS Corporation	2018	—
+4	K183402	PRO-LITE Sterilization Tray	STERIS Corporation	2019	—
+5	K222440	Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization…	Steris	2022	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0
2016	1	0
2018	1	0
2019	2	0
2022	1	0
2023	2	0

FIG. 1 — Lineage of K103226, 2002–2023Source: 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 KCT? 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 KCT device

#1 K214041 Aesculap AICON Containerscore 18.1 · 6 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

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
*	K013003	Aptimax Instrument Tray, Instrument Mat and Instrument Holder Summary page 2 …80.6850 Product Code KCT 2. Predicate Device APTIMAX Instrument Tray, Instrument Tray Holder, and Instrument Tray Mat (K013003) 3. Description of Device The sterilization mats are used to cushion and stabilize devices placed into the V-PRO St…	Advanced Sterilization Products	2002	—

Also cleared against K013003: 4 other devices →

What descends from it? (8)

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

Number	Device	Applicant	Decided	Descendants
K140494	V-Pro Sterilization Tray/ Sterilization Mat	STERIS Corporation	2014	7

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?

Its one ancestor has no recall.
Of its descendants, K140494 (STERIS Corporation, 2014) has gone furthest, with 7 descendants of its own.
4 other devices also cite its predicate K013003.

How does its category compare?

All KCT devices

KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · KCT

11in 2025

2007high 18 (2019) · low 3 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KCT

205in 2025

2007high 236 (2012) · low 89 (2009)2026

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

Recalls per year · KCT

17in 2022

2007high 17 (2022) · low 0 (2007)2026

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

Adverse event reports per year · KCT

50in 2025

2007high 66 (2020) · low 2 (2007)2025

MAUDE reports naming product code KCT, 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	3	199	0	2
2008	6	182	0	8
2009	6	89	0	5
2010	12	202	1	3
2011	6	117	2	3
2012	10	236	0	2
2013	8	131	1	6
2014	11	169	1	5
2015	15	151	0	6
2016	12	182	3	16
2017	10	211	1	3
2018	15	192	0	22
2019	18	187	0	15
2020	14	134	0	66
2021	18	185	1	26
2022	11	137	17	8
2023	10	94	0	30
2024	8	106	0	18
2025	11	205	0	50
2026	9	122	0	—

What is it indicated for?

The sterilization mats are intended to be used in conjunction with the V-PROTM Sterilization Trays (K(070769) to cushion and stabilize instruments during sterilization in the Amsco® V-PRO Low Temperature Sterilization Systems. The sterilization mats have been validated for use in the three pre-programmed V-PRO sterilization cycles [Lumen Cycle (the only cycle of the V-PRO I Sterilizer), Non Lumen Cycle, and Flexible Cycle]. The critical parameters for…

Read the full statement (587 words)

The sterilization mats have been validated for use in the three pre-programmed V-PRO sterilization cycles [Lumen Cycle (the only cycle of the V-PRO I Sterilizer), Non Lumen Cycle, and Flexible Cycle]. The critical parameters for each of these cycles are listed below.

The Lumen Cycle, cleared under K062297, can sterilize:

• Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors

• Medical devices with a single stainless steel lumen with:

• an inside diameter of 1 mm or larger and a length of 125 mm or shorter

• an inside diameter of 2 mm or larger and a length of 250 mm or shorter

• an inside diameter of 3 mm or larger and a length of 400 mm or shorter

The validation testing for all lumen sizes was conducted using a maximum of twenty (20) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load consisting of two instrument trays (containing two mats and 20 instrument organizers) and two pouches for a total weight of 19.65 lbs.

The Non Lumen Cycle, cleared under K083097, can sterilize:

Non-lumened instruments including non-lumened instruments with stainless steel diffusion-restricted areas such as the hinged portion of forceps or scissors.

The validation studies were conducted using a validation load consisting of two instrument trays containing two mats, and 20 instrument organizers and two pouches for a total weight of 19.65 lbs.

The Flexible Cycle, subject of K102330, can sterilize:

Single or dual lumen surgical flexible endoscopes and bronchoscopes in either of two load configurations:

1. Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load.

The flexible endoscopes may contain either:

• a single Teflon lumen with an inside diameter of 1 mm or larger and a length of 1050 mm or shorter

• or two Teflon lumens with:

• one lumen having an inside diameter of 1 mm or larger and a length of 998 mm or shorter

• and the other lumen having an inside diameter of 1 mm or larger and a length of 850 mm or shorter

The validation studies were conducted with two flexible endoscopes, each packaged into a tray with silicone mat, 20 instrument organizers and light cord (if not integral to endoscope).

2. One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments including instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors.

The flexible endoscope can contain either:

• a single Teflon lumen with an inside diameter of 1 mm or larger and a length of 1050 mm or shorter

• or two Teflon lumens with:

• one lumen having an inside diameter of 1 mm or larger and a length of 998 mm or shorter

• and the other lumen having an inside diameter of 1 mm or larger and a length of 850 mm or shorter

The validation studies were conducted with a flexible endoscope in a tray with silicone mat, 20 instrument organizers and light cord (if not integral to endoscope). Also included in the load were an additional instrument tray (containing a mat and 20 instrument organizers) and one pouch for a total load weight of 24.0 lbs.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K103226 · printed Nov 6, 2026

Cite this page

510(k) Report. “K103226: Sterilization Mats.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103226

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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