510(k) · Cleared
ClearedCarr Rigid Container System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carr Metal Products, Inc. · FRG Wrap, Sterilization
Cleared on Nov 13, 1997 as substantially equivalent to K792558 (Aesculap Instruments Corp., 1979) and 3 other predicates after a 160-day review. Its family tree reaches back 1 generation to 1979.
- Decided
- Nov 13, 1997
- Review
- 160 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K792558 (1979). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK792558 Container SystemAesculap Instruments Corp. · 1979
- This deviceK972138 Carr Rigid Container SystemCarr Metal Products, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K792558 | Container System | Aesculap Instruments Corp. | 1979 | — |
| 0 (this device) | K972138 | Carr Rigid Container System | Carr Metal Products, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 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? (4)
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 |
|---|---|---|---|
| * | K792558 | Container SystemSummary page 1…Common/Ususal Name: Sterilization Container - rigid Classification Name: Sterilization wrap Device: Carr Sterilization Container system Predicate Devices: Aesculap - K792558, Medin - K833343, InstruMed - KB44672 and Riley - K871202 [Device Description: | A rigid container system include a base availa… | 1979 |
| * | K833343 | Sterilization ContainerSummary page 1…me: Sterilization Container - rigid Classification Name: Sterilization wrap Device: Carr Sterilization Container system Predicate Devices: Aesculap - K792558, Medin - K833343, InstruMed - KB44672 and Riley - K871202 [Device Description: | A rigid container system include a base available in scveral de… | 1983 |
| * | K844672 | InstrutainerSummary page 3…in independent testing Yes Yes Yes Yes Yes Yes Yes Yes Yes Claimed by Acsculap K792558 Claimed by Aesculsp K792558 On Aesculap K792558 Claimed by intsruMed K844672 Assumed provided Claimed by Medin K833343, InstruMed KB844672 Assumed Assumed InstruMed K844672 Non-Confident… | 1985 |
| * | K871202 | Flashpak Container SystemSummary page 1…ification Name: Sterilization wrap Device: Carr Sterilization Container system Predicate Devices: Aesculap - K792558, Medin - K833343, InstruMed - KB44672 and Riley - K871202 [Device Description: | A rigid container system include a base available in scveral depth sizes (2.57,3.0°,3.5”, 4.0 and 5.0”) a… | 1987 |
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?
- None of the 4 ancestors has a recall.
- 6 other devices also cite its predicate K792558.
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?
Container system designed to contain medical and dental (excluding dental hand pieces) instruments for sterilization and storage. This device is intended to be used and handled by healthcare personnel. This container system is suitable for Pre-vacuum steam and EO sterilization. Sterility assurance tested up to 30 days.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972138 · printed Nov 5, 2026
Cite this page
510(k) Report. “K972138: Carr Rigid Container System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K972138
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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