# K001988: Modular

- Pathway: 510(k) (Traditional)
- Applicant: Heyer America, Inc.
- Decided: Feb 5, 2001 after 221 days
- Product code: BSZ (Gas-Machine, Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.5160
- 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.
12 later devices descend from it; 1 cites it directly.
1 of 13 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K080175: Navigator Anesthesia Delivery System, Model 0998-00-3024-01 (2008), 11 descendants of its own
- K102471: AS3700 Anesthsia Delivery System (2011), 9 descendants of its own
- K123211: A5 Anesthesia Delivery System (2013), 8 descendants of its own
- K142552: A7 Anesthesia System (2015), 5 descendants of its own
- K151954: A7 Anesthesia System (2015), 4 descendants of its own

## Recalls of this device
- Mar 17, 2006 · Not classified · Z-0929-06: The Anestar and Anestar Plus Anesthesia System may produce periods of high Positive End-Expiratory Pressure (PEEP), in both manual and mechanical ventilation mode due to an issue with the Applied Pres

Source page: https://510kreport.com/device/K001988
Methodology: https://510kreport.com/methodology