510(k) · Cleared
ClearedSterilucent Self-Seal Sterilization Pouch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gs Medical Packaging, Inc. · FRG Wrap, Sterilization
Cleared on Dec 3, 2014 as substantially equivalent to K070765 (STERIS Corporation, 2007) after a 188-day review. Its family tree reaches back 2 generations to 1977.
- Decided
- Dec 3, 2014
- Review
- 188 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K771032 (1977). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K771032 | Pouches, Peel Open, Breathable | Surgicot, Inc. | 1977 | — |
| −1 | K070765 | Vis-U-All II Self Seal Pouch | STERIS Corporation | 2007 | — |
| 0 (this device) | K141412 | Sterilucent Self-Seal Sterilization Pouch | Gs Medical Packaging, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 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 |
|---|---|---|---|
| * | K070765 | Vis-U-All II Self Seal PouchSummary page 6…Accessories Product Code: FRG (21 CFR 880.6850) Class: II 2. Predicate Device Steris Vis-U-All Self Seal Pouch (K070765) 3. Device Description The Sterilucent Self-Seal Sterilization Pouch is a self sealing pouch used to enclose another medical d… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 37 years and passes through 3 companies; a new generation was cleared every 30.2 years on median.
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K070765.
How does its category compare?
All FRG devicesFRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
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 Sterilucent Self-Seal Sterilization Pouch is intended to be used to enclose medical devices that are to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. The pouches are intended to be used in the Sterilucent PSD-85 Hydrogen Peroxide Sterilizer Lumen and Non-Lumen Cycles. Pouch Models and Sizes Catalog No. Size SL264 3.5” x 9”…
Read the full statement (220 words)
The Sterilucent Self-Seal Sterilization Pouch is intended to be used to enclose medical devices that are to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. The pouches are intended to be used in the Sterilucent PSD-85 Hydrogen Peroxide Sterilizer Lumen and Non-Lumen Cycles.
Pouch Models and Sizes
Catalog No. Size
SL264 3.5” x 9”
SL265 4” x 22”
SL266 5.25” x 10”
SL267 5” x 15”
SL268 7.5” x 13”
SL269 12” x 15”
SL270 12” x 18”
The PSD-85 Lumen Cycle has been validated to sterilize a load of up to ten (10) pounds (combined pouch and wrapped tray load) containing a maximum of ten (10) single channel stainless steel lumens per load with the following dimensions:
• An inside diameter of 1 mm or larger and a length of 60 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 350 mm or shorter.
The PSD-85 Non-Lumen Cycle has been validated to sterilize a load of up to 25 pounds (combined pouch and wrapped tray load).
The maximum validated pouch load is two (2) pounds.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141412 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141412: Sterilucent Self-Seal Sterilization Pouch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141412
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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