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MAXO2+, Model a and Ae

by Maxtec, Inc.

510(k) K040484

MAXO2+, Model a and Ae is a Class II device made by Maxtec, Inc., cleared under FDA 510(k) K040484 on 9 Jun 2004, 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 NumberK040484 Date9 Jun 2004ClearedStatusActive

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  • Withdrawn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
CCL
Device class
Class II
Regulation
21 CFR Part 868.1720
Advisory committee
Anesthesiology
FDA decision
SESE Substantially Equivalent

Related clearances

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

Cited by

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

Devices cleared under K040484

20 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 K040484
UDI-DISize and differences
Analyzer MaxO2+
Maxtec, Inc.
R217P62-008 / MaxO2+00817770025948
Prescription: yes
On the market
Analyzer MaxO2+
Maxtec, Inc.
R219P20-009 / MaxO2+00817770025849
Prescription: yes
On the market
Analyzer MaxO2+
Maxtec, Inc.
R233P04-005 / MaxO2+00817770025931
Prescription: yes
On the market
BIO MED R219P62-001
Maxtec, Inc.
R219P62-00100817770021018
Prescription: no
No longer on the market
BlenderBuddy2 R233P04-001
Maxtec, Inc.
R233P04-00100817770021704
Prescription: no
On the market
BlenderBuddy2 R233P04-002
Maxtec, Inc.
R233P04-00200817770021728
Prescription: no
On the market
BlenderBuddy2 R233P04-003
Maxtec, Inc.
R233P04-00300817770021711
Prescription: no
On the market
BlenderBuddy2 R233P04-004
Maxtec, Inc.
R233P04-00400817770021735
Prescription: no
On the market
MAX02+ R217P72-003
Maxtec, Inc.
R217P72-00300817770020684
Prescription: yes
On the market
MAX02+A INTERNATIONAL ANALYZER R217P62-007
Maxtec, Inc.
R217P62-00700817770021308
Prescription: no
No longer on the market
MAX02+AE OHIO ANALYZER R217P72-005
Maxtec, Inc.
R217P72-00500817770021346
Prescription: no
On the market
MaxO2+ A Medical R217P62
Maxtec, Inc.
R217P6200853061006982
Prescription: no
On the market
MaxO2+ AE R217P72
Maxtec, Inc.
R217P7200853061006937
Prescription: no
On the market
MAXO2+ R217P62-002
Maxtec, Inc.
R217P62-00200817770020660
Prescription: no
On the market
MAXO2+ R217P62-004
Maxtec, Inc.
R217P62-00400817770020677
Prescription: no
No longer on the market
MAXO2+ R219P17-003
Maxtec, Inc.
R219P17-00300817770020943
Prescription: no
No longer on the market
MAXO2+ R219P20-003
Maxtec, Inc.
R219P20-00300817770020950
Prescription: no
On the market
MAXO2+ R219P20-004
Maxtec, Inc.
R219P20-00400817770020967
Prescription: no
On the market
MAXO2+A OHIO ANALYZER R217P62-006
Maxtec, Inc.
R217P62-00600817770021292
Prescription: no
On the market
MAXO2+AE INTERNATIONAL R217P72-006
Maxtec, Inc.
R217P72-00600817770021315
Prescription: no
No longer on the market

Similar devices

Other devices filed under FDA product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase).

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