# K961339: Carbo Brand/Viva Brand Acupuncture Needles

- Pathway: 510(k) (Traditional)
- Applicant: Helio Medical Supplies, Inc.
- Decided: Jul 3, 1996 after 86 days
- Product code: MQX (Needle, Acupuncture, Single Use)
- Device class: 2
- Regulation: 21 CFR 880.5580
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 4 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K052731: Kangsheng Brand/Kangnian Brand/Unilink Brand/Huazhong Brand Acupuncture Needles (2006), 1 descendant of its own
- K983800: DN Acupunture Needles (1999), 1 descendant of its own
- K981272: Addiquip Disposable Acupuncture Needles (1998), 1 descendant of its own
- K092240: Acupuncture Needles (2010), 0 descendants of its own
- K090199: Jiajian Acupuncture Needle (2009), 0 descendants of its own

Source page: https://510kreport.com/device/K961339
Methodology: https://510kreport.com/methodology