510(k) · Cleared
ClearedCareGUARD Sterilization Wrap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Care Essentials Pty, Ltd. · FRG Wrap, Sterilization
Cleared on Mar 14, 2022 as substantially equivalent to K082554 (Kimberly-Clark Corp., 2009) after a 90-day review. Its family tree reaches back 2 generations to 1988.
- Decided
- Mar 14, 2022
- Review
- 90 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K881471 (1988). No later device cites it as a predicate yet.
- Root · 2 generations backK881471 Kimguard (Regular & Heavy Duty) Sterile WrapKimberly-Clark Corp. · 1988 · Recalled
- 1 generation backK082554 Kimguard Sterilization Wrap, Models KC100, KC200, KC300, KC400…Kimberly-Clark Corp. · 2009
- This deviceK213907 CareGUARD Sterilization WrapCare Essentials Pty, Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K881471 | Kimguard (Regular & Heavy Duty) Sterile Wrap | Kimberly-Clark Corp. | 1988 | 1 |
| −1 | K082554 | Kimguard Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC500 and KC600 | Kimberly-Clark Corp. | 2009 | — |
| 0 (this device) | K213907 | CareGUARD Sterilization Wrap | Care Essentials Pty, Ltd. | 2022 | — |
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 |
|---|---|---|---|
| * | K082554 | Kimguard Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC500 and KC600Summary page 4…Regulation #: 21 CFR 880.6850 Predicate Device: Kimberly-Clark* Corporation KIMGUARD* Sterilization Wrap – K082554 Page 1 of 9 Device Descri… | 2009 |
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 34 years and passes through 2 companies; a new generation was cleared every 20.7 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 3 other devices also cite its predicate K082554.
How does its category compare?
All FRG devicesFRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
CareGUARD* Sterilization Wrap is a single-use, non-woven sterilization wrap intended to be sterilized by a health care provider using pre-vacuum steam at 273°F / 134°C for 4 minutes. The CareGUARD* Sterilization Wrap was validated for a dry time of 30 minutes. The CareGUARD* Sterilization wrap is recommended to be used with trays weighing up to 13.7 lbs. The wrap is intended to allow sterilization of the enclosed medical device(s) and maintain sterility…
Read the full statement (184 words)
CareGUARD* Sterilization Wrap is a single-use, non-woven sterilization wrap intended to be sterilized by a health care provider using pre-vacuum steam at 273°F / 134°C for 4 minutes. The CareGUARD* Sterilization Wrap was validated for a dry time of 30 minutes. The CareGUARD* Sterilization wrap is recommended to be used with trays weighing up to 13.7 lbs.
The wrap is intended to allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) until used.
Test results validated that CareGUARD™* Sterilization wraps allowed sterilization of the enclosed devices by pre-vacuum cycles.
Refer to Table 1 for recommendations for use per Pre-vacuum steam Sterility Maintenance Study.
Table 1: Basis weight recommendations for pre-vacuum steam
Basis Weight Maximum Wrapped Package Content Weight
50 GSM
60 GSM 6.2 kg/ 13.7 lbs
75 GSM
The following load was used in the Pre-vacuum steam Sterility Maintenance Study:
* 50GSM: 21 in. x 10 in. x 4 % in. (54 cm x 25 cm x 12 cm) tray containing 13.7 lbs (6.2 kg) of metal mass
The metal mass included surgical instruments used for orthopedic joint replacement
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/K213907 · printed Nov 3, 2026
Cite this page
510(k) Report. “K213907: CareGUARD Sterilization Wrap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K213907
Report an extraction error
Are you the manufacturer?
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