510(k) · Cleared

Cleared

Aptimax Instrument Tray, Instrument Mat and Instrument Holder

K013003510(k) TraditionalCleared Aug 28, 2002356-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

Advanced Sterilization Products · FRG Wrap, Sterilization

Cleared on Aug 28, 2002 after a 356-day review. The FDA summary names its predicate without a number. 83 later devices descend from it.

Decided: Aug 28, 2002
Review: 356 days
Class: Class II
Product code: FRG
Recalls: None
Predicates: 0

83 later devices descend from it, 5 citing it directly.

This deviceK013003 Aptimax Instrument Tray, Instrument Mat and Instrument HolderAdvanced Sterilization Products · 2002
Descendant · cites it directly · 46 of its ownK040223 Polyvac Instrument Delivery SystemSymmetry Medical USA, Inc. · 2004
Descendant · 2 generations on · 30 of its ownK131455 Restore Modular Sterilization Tray SystemRestore Medical Solutions, Inc. · 2013
Descendant · 2 generations on · 30 of its ownK120947 THS Instrument TrayHologic, Inc. · 2012
Descendant · 3 generations on · 29 of its ownK152241 Medtronic Transportation/Sterilization CassettesMedtronic Sofamor Danek USA, Inc. · 2016
Descendant · cites it directly · 22 of its ownK103213 Finess Endoscope Sterilization TrayEntellus Medical, Inc. · 2011

Showing 5 of 83 descendants. See all descendants

Descendants cleared per year

2004high 11 (2019) · low 0 (2005)2026

Most influential descendants

Showing 5 of 83 · See all

K040223Polyvac Instrument Delivery SystemSymmetry Medical USA, Inc. · 2004 · cites it directly46descendants
K131455Restore Modular Sterilization Tray SystemRestore Medical Solutions, Inc. · 2013 · 2 generations on30descendants
K120947THS Instrument TrayHologic, Inc. · 2012 · 2 generations on30descendants
K152241Medtronic Transportation/Sterilization CassettesMedtronic Sofamor Danek USA, Inc. · 2016 · 3 generations on29descendants
K103213Finess Endoscope Sterilization TrayEntellus Medical, Inc. · 2011 · cites it directly22descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K013003	Aptimax Instrument Tray, Instrument Mat and Instrument Holder	Advanced Sterilization Products	2002	—
+1	K040223	Polyvac Instrument Delivery System	Symmetry Medical USA, Inc.	2004	—
+2	K131455	Restore Modular Sterilization Tray System	Restore Medical Solutions, Inc.	2013	—
+2	K120947	THS Instrument Tray	Hologic, Inc.	2012	—
+3	K152241	Medtronic Transportation/Sterilization Cassettes	Medtronic Sofamor Danek USA, Inc.	2016	—
+1	K103213	Finess Endoscope Sterilization Tray	Entellus Medical, Inc.	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2007	1	0
2008	1	0
2009	1	0
2010	1	0
2011	3	0
2012	3	0
2013	4	0
2014	5	0
2015	2	0
2016	3	0
2017	3	0
2018	6	0
2019	11	0
2020	2	0
2021	6	0
2022	3	0
2023	6	0
2024	5	0
2025	7	0
2026	9	0

FIG. 1 — Lineage of K013003, 2002–2026Source: 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 FRG? 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 FRG device

#1 K234050 HALYARD® ONE-STEP® Sterilization Wrap…score 15.8 · 7 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? (3)

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	Recalls
*	—	APTIMAX Instrument Tray for use in the STERRAD Sterilization System Named without a submission number	—
*	—	STERRAD Instrument Tray Named without a submission number	—
*	—	Instrument Management System Named without a submission number	—

What descends from it? (83)

See all 83

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

Number	Device	Applicant	Decided	Descendants
K040223	Polyvac Instrument Delivery System	Symmetry Medical USA, Inc.	2004	46
K103213	Finess Endoscope Sterilization Tray	Entellus Medical, Inc.	2011	22
K070769	VHP 136 Tray	STERIS Corporation	2007	10
K103226	Sterilization Mats	STERIS Corporation	2011	8
K234082	STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104)…	Advanced Sterilization Products	2024	2

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, K040223 (Symmetry Medical USA, Inc., 2004) has gone furthest, with 46 descendants of its own.

How does its category compare?

All FRG devices

FRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FRG

9in 2025

2007high 12 (2015) · low 2 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRG

151in 2025

2007high 260 (2017) · low 110 (2011)2026

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

Recalls per year · FRG

2in 2022

2007high 29 (2017) · low 0 (2007)2026

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

Adverse event reports per year · FRG

18in 2025

2007high 22 (2018) · low 0 (2010)2025

MAUDE reports naming product code FRG, 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	182	0	1
2008	2	—	0	2
2009	4	171	0	2
2010	4	213	0	0
2011	6	110	0	12
2012	10	133	0	4
2013	6	146	2	5
2014	8	177	0	13
2015	12	196	0	9
2016	9	131	0	20
2017	9	260	29	7
2018	5	150	0	22
2019	9	258	0	10
2020	5	122	14	21
2021	4	170	0	9
2022	9	217	2	4
2023	9	230	0	13
2024	11	182	0	21
2025	9	151	0	18
2026	4	247	0	—

What is it indicated for?

The APTIMAX Instrument Trays and accessories are designed to encase surgical instruments for sterilization.

The APTIMAX Instrument Trays and accessories were previously indicated for use only with the Sterrad Sterilization Systems. This Premarket Notification expands the Indications for Use for the APTIMAX Instrument Trays and accessories to also include their use in prevacuum steam and ethylene oxide sterilization cycles.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K013003 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013003: Aptimax Instrument Tray, Instrument Mat and Instrument Holder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013003

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026