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Flocap

by Maxtec, Inc.

510(k) K133540

Flocap is a Class II device made by Maxtec, Inc., cleared under FDA 510(k) K133540 on 28 Mar 2014, 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 NumberK133540 Date28 Mar 2014ClearedStatusActive

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  • Withdrawn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
CCK
Device class
Class II
Regulation
21 CFR Part 868.1400
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

Cited by

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

Devices cleared under K133540

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 K133540
UDI-DISize and differences
Ventlab R500P21
Ventlab Corp.
R500P21 / R500P2110889483227046 —No longer on the market
Ventlab R500P30
Ventlab Corp.
R500P30 / R500P3010889483227022 —No longer on the market
Ventlab R500P31
Ventlab Corp.
R500P31 / R500P3110889483228364 —No longer on the market
Ventlab R500P32
Ventlab Corp.
R500P32 / R500P3210889483228371 —No longer on the market

Similar devices

Other devices filed under FDA product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase).

Other devices from Maxtec, Inc.

See all devices from Maxtec, Inc. →