Eli 280 BUR280-81X

by Mortara Instrument, Inc.

Eli 280 BUR280-81X is a Class II device made by Mortara Instrument, Inc., cleared under FDA 510(k) K122073 on 2 Aug 2012 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00812345024890), active as of 22 Oct 2026. 2 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00812345024890 UDI-DI	Date24 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK122073	Date2 Aug 2012Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00812345024890
FDA 510(k) database 510(k) number K122073

Across registries

2 registries list this device

FDA 510(k) K122073 decided 2 Aug 2012 Active
FDA GUDID UDI-DI 00812345024890 listed 24 Sep 2016 Listed

Recalls

2 recalls · 1 ongoing · FDA

- Ongoing Z-0011-2022 FDA Class II initiated 3 Sep 2021
The devices malfunction under specific operator workflows.
- Terminated Z-1482-2021 FDA Class II initiated 31 Mar 2021
Devices do not meet IEC 60601-2-27 requirements as labeled.

Timeline

4 dated events

2 Aug 2012 Cleared FDA 510(k) K122073
24 Sep 2016 Listed FDA GUDID 00812345024890
31 Mar 2021 Recall initiated FDA recalls Z-1482-2021
3 Sep 2021 Recall initiated FDA recalls Z-0011-2022

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Eli 280
Generic name: Electrocardiograph, professional, multichannel
Model / reference: BUR280-81X

Primary DI / UDI-DI: 00812345024890
510(k) Number: K122073
FDA product code: DPS
GMDN term: Electrocardiograph, professional, multichannel

Device class: Class II
Regulation number: 870.2340
GUDID distribution status: In Commercial Distribution

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Other devices filed under Electrocardiograph, professional, multichannel.

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Properties

Prescription use
Serial number

Other properties (13, all answered No)