# K091939: Thermedx Prodigy Fluid Management System, Models P1000, P2000

- Pathway: 510(k) (Traditional)
- Applicant: Thermedx, LLC
- Decided: Jul 23, 2010 after 388 days
- Product code: HIG (Insufflator, Hysteroscopic)
- Device class: 2
- Regulation: 21 CFR 884.1700
- 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: 3 generations back to K873435 (1987). 7 ancestors in all.
4 later devices descend from it; 1 cites it directly.
2 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060939: Ranger Irrigation Fluid Warming System, Arizant Healthcare, Inc. (2006) Summary page 1.
- K072080: Normoflo Irrigation Fluid Warmer, Models H-1100, H-1129, Normoflo Irrigation Warming Set, Models, IR-40, IR-500, IR-600,, Smiths Medical Asd, Inc. (2008) Summary page 1.
- K011876: Dolphin II Fluid Management System, Model Dol-2, Circon Video (2002)

## Cited in the summary but kept off the family tree
- K050058: Theken Reveal VBR System, Theken Surgical,Llc (2005). The summary prints BK050058, a CBER number, which our reading took as K050058, FDA’s number for Theken Reveal VBR System (Theken Surgical,Llc). Its FDA name has none of the distinctive words the summary uses for the device it names, “Fluido®&Blood and Fluid Warmer”. Kept off the family tree. Summary page 1.
- K070755: Interworks, Avreo, Inc. (2007). Our reading of the summary gave K070755, FDA’s number for Interworks (Avreo, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Fluido Accessories”. Kept off the family tree.

## Most influential descendants
- K133799: Thermedx Fluid Managment System (2014), 3 descendants of its own
- K172048: FluidSmart (2017), 2 descendants of its own
- K251273: Asurys Fluid Management System (2026), 0 descendants of its own
- K210628: X-FLO Fluid Management System (2021), 0 descendants of its own

## Recalls of this device
- Sep 1, 2014 · Class II · Z-1463-2015: To correct software bugs that could affect the ability to accurately measure fluid deficit.
- Feb 10, 2014 · Class II · Z-2555-2014: A vendor changed the manufacturing process of a component used in the canister ring that may affect the performance of the ring. The deficit display may be higher than the actual deficit when the flui

## Indications for use
The 37-5 is a multi-purpose fluid management system indicated for the following: * Laparoscopy: warming fluids for irrigation and aspiration * Hysteroscopy: uterine distention during diagnostic and operative procedures * Cystoscopy: distention of the bladder during diagnostic and operative procedures (with optional fluid warming) * Arthroscopy: distention and irrigation of the knee, shoulder, and small joints, during diagnostic and operative procedures During hysteroscopic, cystoscopic and arthroscopic procedures, the 37-5 can be used to monitor fluid deficit.

Source page: https://510kreport.com/device/K091939
Methodology: https://510kreport.com/methodology