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Polytech Filter 100760EN

by Polytechnic Resources, Inc.

Polytech Filter 100760EN is a pulmonary function testing kit (FDA Class II; FDA product code BZG, Spirometer, Diagnostic) made by Polytechnic Resources, Inc., cleared under FDA 510(k) K042758 on 29 Aug 2005 and listed in FDA GUDID since 2 Dec 2016 (UDI-DI B446100760EN1), active as of 23 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K042758

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB446100760EN1 UDI-DI Date2 Dec 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK042758 Date29 Aug 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K042758 decided 29 Aug 2005 Active
  • FDA GUDID UDI-DI B446100760EN1 listed 2 Dec 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K042758
  2. Listed FDA GUDID B446100760EN1

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Polytech Filter
Generic name
Pulmonary function testing kit
Model / reference
100760EN
Primary DI / UDI-DI
B446100760EN1
510(k) Number
FDA product code
BZG
GMDN term
Pulmonary function testing kit
Device class
Class II
Regulation number
868.1840
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 38.8 Millimeter

Related devices

Category: Pulmonary function testing kit

Cleared under the same submission (K042758)

and 8 more cleared under K042758

Similar devices

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

Other devices from Polytechnic Resources, Inc.

See all devices from Polytechnic Resources, Inc. →

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Serial number
Other properties (11, all answered No)