510(k) · Cleared
Recalled · Class III · 2013Steritite Perforated Base Rigid Reusable Sterilization Container System with SCF02-Polypropylene Non-Woven Disposable FI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Case Medical, Inc. · FRG Wrap, Sterilization
Cleared on Mar 21, 2003 as substantially equivalent to K991023 (Case Medical, Inc., 2000) after a 3-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it. It has been recalled once.
- Decided
- Mar 21, 2003
- Review
- 3 days
- Class
- Class II
- Product code
- FRG
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K991023 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK991023 Steritite Perforated Bottom Rigid Reusable Sterilization Container…Case Medical, Inc. · 2000
- This deviceK030853 Steritite Perforated Base Rigid Reusable Sterilization Container…Case Medical, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK161415 SteriTite Containers System & MediTray ProductsCase Medical, Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- K161415SteriTite Containers System & MediTray ProductsCase Medical, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991023 | Steritite Perforated Bottom Rigid Reusable Sterilization Container System with… | Case Medical, Inc. | 2000 | — |
| 0 (this device) | K030853 | Steritite Perforated Base Rigid Reusable Sterilization Container System with… | Case Medical, Inc. | 2003 | — |
| +1 | K161415 | SteriTite Containers System & MediTray Products | Case Medical, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K991023 | Steritite Perforated Bottom Rigid Reusable Sterilization Container System with SCF02 -…Summary page 2…tion of 10” in totul height or 8” high for any one container were tested and found to be efficacious. The same combinations wcre previously validated in the piior 5 1 Ok K991023 for the STERILAD 100 System. Additional studies were pedionned to demonstratc the effects of sterilant volume on microbi… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161415 | SteriTite Containers System & MediTray Products | 2017 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 3, 2013 | Class III | Z-0434-2014 | Device Design | Advanced Sterilization Products (ASP) is recalling the SteriTite containers because they do not have consistent data to show that sterility assurance level of 10(-6) is achieved during the half-cycle test runs on new, unprocessed… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All FRG devicesFRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FRG
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRG
151in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRG
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FRG
18in 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 SteriTite® perforated base containers using polypropylene nonwoven Disposable Filter # SCF02 may be used for the sterilization of surgical instruments in STERRAD 100s Sterilization for a hospital or other health care facilities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030853 · printed Nov 4, 2026
Cite this page
510(k) Report. “K030853: Steritite Perforated Base Rigid Reusable Sterilization Container System with SCF02-Polypropylene Non-Woven Disposable FI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030853
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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