# K030379: Aplab, Model 801D0030

- Pathway: 510(k) (Traditional)
- Applicant: Sector Medical Corp.
- Decided: Aug 29, 2003 after 205 days
- Product code: MNR (Ventilatory Effort Recorder)
- Device class: 2
- Regulation: 21 CFR 868.2375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K913396 (1992). 7 ancestors in all.
98 later devices descend from it; 3 cite it directly.
0 of 106 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012085: Somno Star & Series Sleep System, Sensor Medics Corp. (2001)
- K020607: Sleepflo, Model 101501, Biomec, Inc. (2002)

## Most influential descendants
- K041904: Compass F10 System (2004), 54 descendants of its own
- K073682: Embletta Gold (2008), 41 descendants of its own
- K041724: Compass M10 System (2004), 41 descendants of its own
- K040576: Micromesam Basic-Set (2004), 31 descendants of its own
- K061405: Apnealink, Model 22302 (2006), 30 descendants of its own

## Indications for use
ApLab is intended for use in recording respiratory nasal pressure during sleep. The device is intended for use as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's score.

Source page: https://510kreport.com/device/K030379
Methodology: https://510kreport.com/methodology