# K032393: Induction and Sampling Manifold (or Stopcock)

- Pathway: 510(k) (Traditional)
- Applicant: Elcam Medical Acal
- Decided: Sep 12, 2003 after 39 days
- Product code: FMG (Stopcock, I.V. Set)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K862691 (1986). 3 ancestors in all.
18 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000152: Kippmed I.V. Manifold, The Kipp Group (2000)
- K022895: Elcam Stopcocks and Manifolds, Medical Device Consultants, Inc. (2002)

## Most influential descendants
- K033793: Cleaner II Rotational Thrombectomy System (2003), 12 descendants of its own
- K040252: Cleaner Rotational Thrombectomy System Kit (2004), 11 descendants of its own
- K060904: Cleaner Rotational Thrombectomy System (2006), 10 descendants of its own
- K091029: Cleaner Rotational Thrombectomy System (9 MM X 65 CM) and (9 MM X 120 CM) (2010), 9 descendants of its own
- K120346: Cleaner Rotational Thrombectomy System (2012), 8 descendants of its own

## Recalls of this device
- Oct 29, 2025 · Class II · Z-0644-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Oct 29, 2025 · Class II · Z-0641-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

## Indications for use
Elcam Induction & Sampling Manifold [or Stopcock] is a one or multiple ports product, which is indicated to serve as a flow control and a conduit device for I.V. fluids delivery to the patient’s vascular system. The product is intended for delivering I.V. drugs or fluids, allowing gravity feed, sampling, bolus injection and elimination of reflux of fluids during operation.

Source page: https://510kreport.com/device/K032393
Methodology: https://510kreport.com/methodology