510(k) · Cleared
ClearedJAMBRO Single Core A Sterilization wrap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jiangsu Zhande Medical Supplies Co., Ltd. · FRG Wrap, Sterilization
Cleared on Jun 11, 2019 as substantially equivalent to K160755 (Ahlstrom Nonwovens, LLC, 2016) after a 259-day review. Its family tree reaches back 6 generations to 1988. 1 later device descends from it.
- Decided
- Jun 11, 2019
- Review
- 259 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K881471 (1988). 10 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK881471 Kimguard (Regular & Heavy Duty) Sterile WrapKimberly-Clark Corp. · 1988 · Recalled
- 5 generations backK082177 Kimguard One-Step Sterilization WrapKimberly-Clark Corp. · 2009
- 4 generations backK092167 Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300…Kimberly-Clark Corp. · 2009
- 3 generations backK113806 Kimguard One Step Sterilization WrapKimberly-Clark Health Care · 2013
- 2 generations backK141612 Kimguard One-Step Sterilization WrapKimberly-Clark Health Care · 2014
- 1 generation backK160755 Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization WrapAhlstrom Nonwovens, LLC · 2016
- This deviceK182656 JAMBRO Single Core A Sterilization wrapJiangsu Zhande Medical Supplies Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK220133 Sterilization WrapsWeihai Hongyu Nonwoven Fabric Products Co., Ltd. · 2022
Most influential descendants
Showing 1 of 1 · See all- K220133Sterilization WrapsWeihai Hongyu Nonwoven Fabric Products Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K881471 | Kimguard (Regular & Heavy Duty) Sterile Wrap | Kimberly-Clark Corp. | 1988 | 1 |
| −5 | K082177 | Kimguard One-Step Sterilization Wrap | Kimberly-Clark Corp. | 2009 | — |
| −4 | K092167 | Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400… | Kimberly-Clark Corp. | 2009 | — |
| −3 | K113806 | Kimguard One Step Sterilization Wrap | Kimberly-Clark Health Care | 2013 | — |
| −2 | K141612 | Kimguard One-Step Sterilization Wrap | Kimberly-Clark Health Care | 2014 | — |
| −1 | K160755 | Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap | Ahlstrom Nonwovens, LLC | 2016 | — |
| 0 (this device) | K182656 | JAMBRO Single Core A Sterilization wrap | Jiangsu Zhande Medical Supplies Co., Ltd. | 2019 | — |
| +1 | K220133 | Sterilization Wraps | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 |
|---|---|---|---|
| * | K160755 | Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization WrapSummary page 5…II Product Code: FRG III. PREDICATE DEVICE Ahlstrom Nonwovens LLC’s Reliance® Solo Sterilization Wrap, Reliance® Tandem Sterilization Wrap, K160755 IV. DEVICE DESCRIPTION JAMBRO Single Core A is a 63gsm, latex-free, 3-layer (SMS) non-woven sterile wrap, m… | 2016 |
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 |
|---|---|---|---|
| K220133 | Sterilization Wraps | 2022 | 0 |
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 31 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K220133 (Weihai Hongyu Nonwoven Fabric Products Co., Ltd., 2022) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K160755.
How does its category compare?
All FRG devicesFRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
JAMBRO Single Core A is intended to be used to enclose another medical device that is to be sterilized by a health care provider using: • Gravity steam at 250°F/121°C for 30 minutes • Pre-vacuum steam at 270°F/132°C for 4 minutes Gravity steam and Pre-vacuum steam sterilization: Validated for dry times of 30 minutes for JAMBRO Single Core A Types of medical devices to be sterilized in the gravity cycle; • General purpose non-lumened reusable metal and…
Read the full statement (236 words)
JAMBRO Single Core A is intended to be used to enclose another medical device that is to be sterilized by a health care provider using:
• Gravity steam at 250°F/121°C for 30 minutes
• Pre-vacuum steam at 270°F/132°C for 4 minutes
Gravity steam and Pre-vacuum steam sterilization:
Validated for dry times of 30 minutes for JAMBRO Single Core A
Types of medical devices to be sterilized in the gravity cycle;
• General purpose non-lumened reusable metal and nonmetal devices including devices with stainless steel diffusion-restricted spaces such as the hinged portion of forceps and scissors, as well as other general medical instruments having mated surfaces, knurled areas etc.
Types of medical devices to be sterilized in the pre-vacuum cycle are;
• General purpose reusable metal and nonmetal devices including devices with stainless steel diffusion-restricted spaces such as the hinged portion of forceps and scissors, as well as other general medical instruments having mated surfaces, knurled areas etc.
• Up to 2 single channel stainless steel lumened devices of the following dimensions; An inside diameter of 3 mm or larger and a length of 400 mm or shorter;
Color of wrap: Blue
Size of wrap: 48 in x 48 in
The maximum validated weight of load for JAMBRO Single Core A is 25 lbs.
The wrap is intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility of the enclosed device(s) until used.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182656 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182656: JAMBRO Single Core A Sterilization wrap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182656
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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