510(k) · Cleared

Cleared

Steritite Container with Flashtite Valve Plate (S) & Meditray Products

K022978510(k) TraditionalCleared May 9, 2003245-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

Case Medical, Inc. · FRG Wrap, Sterilization

Cleared on May 9, 2003 as substantially equivalent to K960738 (Engineered Custom Mfg., Inc., 1997) and 3 other predicates after a 245-day review. Its family tree reaches back 1 generation to 1987. 25 later devices descend from it.

Decided: May 9, 2003
Review: 245 days
Class: Class II
Product code: FRG
Recalls: None
Predicates: 5

Its longest line of descent runs back 1 generation to K871202 (1987). 4 ancestors in all. 25 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK871202 Flashpak Container SystemPerformance Instruments Corp. · 1987
This deviceK022978 Steritite Container with Flashtite Valve Plate (S) & Meditray ProductsCase Medical, Inc. · 2003
Descendant · cites it directly · 12 of its ownK053389 Aesculap Sterilcontainer SystemAesculap, Inc. · 2006
Descendant · 2 generations on · 9 of its ownK073168 Aesculap Primeline Container LTD.Aesculap, Inc. · 2008
Descendant · 2 generations on · 7 of its ownK112671 Sterilcontainer SystemAesculap, Ltd. · 2012
Descendant · cites it directly · 7 of its ownK072563 Miltex Rigid Container SystemsMiltex, Inc. · 2008
Descendant · 3 generations on · 5 of its ownK192056 JJ Series Container SystemAesculap, Inc. · 2020

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

2006high 3 (2006) · low 0 (2007)2026

Most influential descendants

Showing 5 of 25 · See all

K053389Aesculap Sterilcontainer SystemAesculap, Inc. · 2006 · cites it directly12descendants
K073168Aesculap Primeline Container LTD.Aesculap, Inc. · 2008 · 2 generations on9descendants
K112671Sterilcontainer SystemAesculap, Ltd. · 2012 · 2 generations on7descendants
K072563Miltex Rigid Container SystemsMiltex, Inc. · 2008 · cites it directly7descendants
K192056JJ Series Container SystemAesculap, Inc. · 2020 · 3 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K871202	Flashpak Container System	Performance Instruments Corp.	1987	—
0 (this device)	K022978	Steritite Container with Flashtite Valve Plate (S) & Meditray Products	Case Medical, Inc.	2003	—
+1	K053389	Aesculap Sterilcontainer System	Aesculap, Inc.	2006	—
+2	K073168	Aesculap Primeline Container LTD.	Aesculap, Inc.	2008	—
+2	K112671	Sterilcontainer System	Aesculap, Ltd.	2012	—
+1	K072563	Miltex Rigid Container Systems	Miltex, Inc.	2008	—
+3	K192056	JJ Series Container System	Aesculap, Inc.	2020	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	3	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	3	0
2008	2	0
2010	2	0
2012	3	0
2014	1	0
2016	1	0
2017	1	0
2018	1	0
2020	2	0
2022	3	0
2024	2	0
2025	3	0
2026	1	0

FIG. 1 — Lineage of K022978, 1987–2026Source: 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? (5)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K960738	Steritite Sealed Container (SC08F,SC06F,SC04F,SC08Q,SC06Q,SC04Q,SC08H,SC06H,SC04H) Summary page 1 …Device; Class II device, product code 8OT;RG Predicate for Flash Sterilization: SteriTits $3 previoidy cleared under K960 738 & K9 74638. 17lrrshPuR K871202,FlashGuardKS416G9 Predicate for McdiTray Produ…	Engineered Custom Mfg., Inc.	1997	1
*	K974638	Steritite Sealed Containers Model SCO4Q Summary page 1 …Class II device, product code 8OT;RG Predicate for Flash Sterilization: SteriTits $3 previoidy cleared under K960 738 & K9 74638. 17lrrshPuR K871202,FlashGuardKS416G9 Predicate for McdiTray Products:…	Case Medical, Inc.	1997	—
*	K871202	Flashpak Container System Summary page 1 …dicate for Flash Sterilization: SteriTits $3 previoidy cleared under K960 738 & K9 74638. 17lrrshPuR K871202,FlashGuardKS416G9 Predicate for McdiTray Products: Stcrilizution Camettes, K962545 Official contact:…	Performance Instruments Corp.	1987	—
Kept off the family tree	K541669	FlashGuard Container System Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree
*	K962545	Dental, Medical Instrument Cases & Cassette Summary page 1 …638. 17lrrshPuR K871202,FlashGuardKS416G9 Predicate for McdiTray Products: Stcrilizution Camettes, K962545 Official contact: Marcia Frieze, CEO, 20 1-313-1999 ext. 225 iNTENDED USE:…	Sterilization Cassette Systems, Inc.	1997	—

Also cleared against K960738: 1 other device →

What descends from it? (25)

See all 25

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

Number	Device	Applicant	Decided	Descendants
K053389	Aesculap Sterilcontainer System	Aesculap, Inc.	2006	12
K072563	Miltex Rigid Container Systems	Miltex, Inc.	2008	7
K173259	Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray…	Case Medical, Inc.	2018	4
K052567	One Tray Sealed Sterilization Container	Sterile Containment Technology, LLC	2006	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?

1 of the 4 ancestors has a recall of any class.
Of its descendants, K053389 (Aesculap, Inc., 2006) has gone furthest, with 12 descendants of its own.
1 other device also cites its predicate K960738.

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 StariTite@containers with r;laslil'ite@ ualvc plate(s) are intcnded to be used in conjunction with MediTray basic tray for the flash sterilization of one iiistrurnent or instrument set. The SteriTile container system with MediTray product are intended to be used to contain niedical devices for steam sterilization. The full line of MediTmy product is intended for complex customizotion in pre-Vacuum steam sterili7atioa MediTray basic trays are intcnded…

Read the full statement (118 words)

The StariTite@containers with r;laslil'ite@ ualvc plate(s) are intcnded to be used in conjunction with MediTray basic tray for the flash sterilization of one iiistrurnent or instrument set.

The SteriTile container system with MediTray product are intended to be used to contain niedical devices for steam sterilization. The full line of MediTmy product is intended for complex customizotion in pre-Vacuum steam sterili7atioa MediTray basic trays are intcnded to be used in the sealed container for sterilization jn steam pre-vacuum and gravity sterilization. MediTray products may be used scparntely for sterilizarion when wnpped in FDA cleared medical grade wrappers.

The MediTny products include casehays with lid and base, insert boxes, casetlcs, trays, baskets, instrument ncks, si1icone mats, brackets, posts, partitions.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K022978 · printed Nov 5, 2026

Cite this page

510(k) Report. “K022978: Steritite Container with Flashtite Valve Plate (S) & Meditray Products.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K022978

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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