510(k) · Cleared
ClearedShangring
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wuhu Snna Medical Treatment Appliance Technology C · HFX Clamp, Circumcision
Cleared on Aug 3, 2012 as substantially equivalent to K032091 (Emergogroup, Inc., 2004) after a 45-day review. Its family tree reaches back 1 generation to 2004. 1 later device descends from it.
- Decided
- Aug 3, 2012
- Review
- 45 days
- Class
- Class II
- Product code
- HFX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K032091 (2004). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K142163Male Circumcision Kits:RapideclampMedicfit Technology Sdn Bhd · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K032091 | Smart Klamp Various by Size | Emergogroup, Inc. | 2004 | — |
| 0 (this device) | K121789 | Shangring | Wuhu Snna Medical Treatment Appliance Technology C | 2012 | — |
| +1 | K142163 | Male Circumcision Kits:Rapideclamp | Medicfit Technology Sdn Bhd | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 HFX? 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 HFX device
- #1 K251687 Konig Bell Circumcision Clampscore 11.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K926353 | FDA’s K926353 is Flowgel (R) Topical Wound Dressing Our reading of the summary gave K926353, FDA’s number for Flowgel (R) Topical Wound Dressing (Mediventures, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Gomco Circumcision Clamp (Thomas Medical Inc.)”. Kept off the family tree. Summary page 1…ecological Panel Product Code: HFX 3. PREDICATE DEVICES * Plastibell (Hollister, pre-amendment device) * Gomco Circumcision Clamp (Thomas Medical Inc., K926353) ry ( , 4C * Smart Klamnp®(Emergo Group, Inc., K032091) 4. DEVICE DESCRIPTION The ShangRing is a steril… | 1994 |
| * | K032091 | Smart Klamp Various by SizeSummary page 1…tibell (Hollister, pre-amendment device) * Gomco Circumcision Clamp (Thomas Medical Inc., K926353) ry ( , 4C * Smart Klamnp®(Emergo Group, Inc., K032091) 4. DEVICE DESCRIPTION The ShangRing is a sterile, single use, disposable circumcision device consisting of two concentric r… | 2004 |
| * | — | Plastibell (Hollister, pre-amendment device) Named without a submission number |
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 |
|---|---|---|---|
| K142163 | Male Circumcision Kits:Rapideclamp | 2015 | 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?
How does its category compare?
All HFX devicesHFX Clamp, Circumcision: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · HFX
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · HFX
Too few HFX 510(k)s in any year since 2007 to give a median.
Recalls per year · HFX
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HFX
122in 2025
MAUDE reports naming product code HFX, 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 | 2 | — | 0 | 17 |
| 2008 | 0 | — | 0 | 6 |
| 2009 | 0 | — | 0 | 20 |
| 2010 | 1 | — | 0 | 21 |
| 2011 | 0 | — | 3 | 12 |
| 2012 | 2 | — | 0 | 14 |
| 2013 | 1 | — | 0 | 16 |
| 2014 | 0 | — | 2 | 20 |
| 2015 | 2 | — | 0 | 21 |
| 2016 | 0 | — | 1 | 147 |
| 2017 | 0 | — | 0 | 25 |
| 2018 | 0 | — | 0 | 13 |
| 2019 | 0 | — | 2 | 11 |
| 2020 | 0 | — | 0 | 22 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 1 | — | 0 | 3 |
| 2023 | 1 | — | 0 | 33 |
| 2024 | 0 | — | 1 | 121 |
| 2025 | 0 | — | 0 | 122 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The ShangRing Tm device is indicated for circumcision of adult males, defined as circumferential excision of the foreskin or prepuce at or near the level of the coronal sulcus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121789 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121789: Shangring.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121789
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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