510(k) · Cleared
ClearedFlashpak Container System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Performance Instruments Corp. · FRG Wrap, Sterilization
Cleared on May 29, 1987 after a 65-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 29 later devices descend from it.
- Decided
- May 29, 1987
- Review
- 65 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 0
29 later devices descend from it, 5 citing it directly.
- This deviceK871202 Flashpak Container SystemPerformance Instruments Corp. · 1987
- Descendant · cites it directly · 25 of its ownK022978 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 · 2 generations on · 7 of its ownK072563 Miltex Rigid Container SystemsMiltex, Inc. · 2008
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K022978Steritite Container with Flashtite Valve Plate (S) & Meditray ProductsCase Medical, Inc. · 2003 · cites it directly25descendants
- 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 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K871202 | Flashpak Container System | Performance Instruments Corp. | 1987 | — |
| +1 | 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 | — |
| +2 | K072563 | Miltex Rigid Container Systems | Miltex, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 3 | 0 |
| 2008 | 2 | 0 |
| 2010 | 2 | 0 |
| 2012 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (29)
See all 295 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K022978 (Case Medical, Inc., 2003) has gone furthest, with 25 descendants of its own.
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 | — |
https://510kreport.com/device/K871202 · printed Nov 6, 2026
Cite this page
510(k) Report. “K871202: Flashpak Container System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K871202
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026