# K942782: Piccolo (TM)

- Pathway: 510(k) (Traditional)
- Applicant: Abaxis, Inc.
- Decided: Mar 13, 1995 after 273 days
- Product code: JJG (Analyzer, Chemistry, Centrifugal, For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2140
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 7 cite it directly.
0 of 11 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
- K171971: Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer (2018), 2 descendants of its own
- K072140: S40 Clinical Analyzer, S Test Bil, S Test Bun, S Test Glu (2008), 1 descendant of its own
- K251074: Tru Liver Health Test Panel (2025), 0 descendants of its own
- K251058: Tru Kidney Health Test Panel; Tru Analyzer (2025), 0 descendants of its own
- K120369: Hitachi Clinical Analyzer S Test Reagent Cartridge Glucose (Glu) (2012), 0 descendants of its own

## Recalls of this device
- Nov 16, 2009 · Not classified · Z-1155-2010: Wrong barcode applied to a lot of items, which may result in incorrect calibration factors and results.

Source page: https://510kreport.com/device/K942782
Methodology: https://510kreport.com/methodology