# K962781: Corometrics Model 510 and 511 Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems Information Technologies
- Decided: Mar 6, 1997 after 232 days
- Product code: BZQ (Monitor, Breathing Frequency)
- Device class: 2
- Regulation: 21 CFR 868.2375
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K871302 (1987). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943308: Model 510 Infant Monitor, Ge Medical Systems Information Technologies (1995) Summary page 1.
- K942170: Model 511 Infant Monitor, Ge Medical Systems Information Technologies (1995). Our OCR of the scanned summary read K942179, FDA’s number for Pro-Tec Disposable Sharps Containers (Pro-Tec Containers, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Model 511”.
- K871302: Model 2000W Option H Configuration, Edentec Corp. (1987) Summary page 1.
- K905575: Modified Models 2000W and 2000W Option H Apnea Mon, Edentec Corp. (1991) Summary page 1.
- K913695: Nellcor (R) N-180 Pulse Oximeter, Nellcor, Inc. (1991) Summary page 1.

## Recalls of this device
- May 24, 2004 · Not classified · Z-1023-04: Device may not alarm for %SpO2 value limit violations if a specific feature is enabled

## Indications for use
These monitors were originally cleared for monitoring respiration, heart rate, optional pulse oximetry and for detecting central apnea in infants in the home and hospital environments.

Source page: https://510kreport.com/device/K962781
Methodology: https://510kreport.com/methodology