# K013093: Pall Ultipor Anesthesia Breathing System

- Pathway: 510(k) (Traditional)
- Applicant: Pall Medical
- Decided: Aug 1, 2002 after 318 days
- Product code: CAH (Filter, Bacterial, Breathing-Circuit)
- Device class: 2
- Regulation: 21 CFR 868.5260
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Zefon Anesthesia Breathing System: named in the summary without a submission number

## Most influential descendants
- K191909: HepaShield Bacterial Viral Breathing System Filter (2020), 2 descendants of its own
- K221836: Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus (2022), 0 descendants of its own
- K210352: GGM Breathing Circuit Bacterial Filter (2022), 0 descendants of its own

## Indications for use
The Pall Ultipor Anesthesia Breathing Circuit System with a Breathing System Filter (“BSF’) is intended for use in the administration of medical gases during anesthesia. The circuit connects the anesthesia gas machine to the patient, by means of an oronasal facemask or by a connection to an artificial airway, such as an endotracheal tube or laryngeal mask. The Pall Ultipor 25 BSF minimizes viral and bacterial contamination of the inspiratory and expiratory limbs of the circuit with a minimum efficiency of 99.999%.

Source page: https://510kreport.com/device/K013093
Methodology: https://510kreport.com/methodology