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ComPAS2

by Morgan Scientific, Inc.

510(k) K213872

ComPAS2 is a medical device (FDA Class II; FDA product code BZG, Spirometer, Diagnostic) made by Morgan Scientific, Inc., cleared under FDA 510(k) K213872 on 15 Jul 2022, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK213872 Date15 Jul 2022ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
BZG
Device class
Class II
Regulation
21 CFR Part 868.1840
Advisory committee
Anesthesiology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K213872

4 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K213872
UDI-DISize and differences
ComPAS2 2022.2.1
Morgan Scientific, Inc.
2022.2.100851845007163
Prescription: no
On the market
ComPAS2 2022.2.2
Morgan Scientific, Inc.
CT1622 / 2022.2.200851845007170
Prescription: no
On the market
ComPAS2 2023.1.0
Morgan Scientific, Inc.
CT1622 / 2023.1.000851845007187
Prescription: no
On the market
comPAS2 2025.1.0
Vitalograph Ireland, Ltd.
91704 / 2025.1.000851845007248
Prescription: yes
On the market

Similar devices

Other devices filed under FDA product code BZG (Spirometer, Diagnostic).

Other devices from Morgan Scientific, Inc.

  • ComPAS 1.10

    Class II

  • ComPAS2 2023.1.0

    Class II

  • ComPAS2 2022.2.2

    Class II

  • ComPAS2 2022.2.1

    Class II

See all devices from Morgan Scientific, Inc. →