# K020954: H/S Procedure Tray (5F), H/S Procedure Tray (7F), H/S Elliptosphere Procedure Tray & Multipurpose Procedure Tray

- Pathway: 510(k) (Special)
- Applicant: Ackrad Laboratories
- Decided: Apr 24, 2002 after 30 days
- Product code: LKF (Cannula, Manipulator/Injector, Uterine)
- Device class: 2
- Regulation: 21 CFR 884.4530
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K881680 (1988). 1 ancestor in all.
7 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K881680: Ackrad H/S Procedure Tray, Ackrad Laboratories (1988) Summary page 1.

## Most influential descendants
- K110288: Femvue Saline-Air Device (2011), 5 descendants of its own
- K241693: FemChec Controlled Saline-Air Device (FCD-250) (2024), 1 descendant of its own
- K253403: FemVue® Controlled Saline-Air Device (FSA-300) (2025), 0 descendants of its own
- K242002: FemVue MINI Saline-Air Device (2024), 0 descendants of its own
- K142545: SonoFlow Sonohysterography and Sonohysterosalpingography Device (2015), 0 descendants of its own

## Indications for use
Procedure trays containing components intended for the delivery of diagnostic contrast media agents in the female reproductive tract for examination of the uterus and fallopian tubes (i.e. Hysterosalpingography or Hysterosonography).

Source page: https://510kreport.com/device/K020954
Methodology: https://510kreport.com/methodology