Skip to content

Rhino-Guard

by Micromedics, Inc.

510(k) K911785

Rhino-Guard is a medical device (FDA Class II; FDA product code CAF, Nebulizer (Direct Patient Interface)) made by Micromedics, Inc., cleared under FDA 510(k) K911785 on 7 Oct 1991, 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 NumberK911785 Date7 Oct 1991ClearedStatusActive

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  • Withdrawn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
CAF
Device class
Class II
Regulation
21 CFR Part 868.5630
Advisory committee
Anesthesiology
FDA decision
SESE Substantially Equivalent

Devices cleared under K911785

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 K911785
UDI-DISize and differences
RG100
Summit Medical, LLC
RG10000385640000260 —On the market
RG250
Summit Medical, LLC
RG25000385640000277 —On the market
SP-30010
Summit Medical, LLC
SP-3001000385640000079 —On the market
SP-30250
Summit Medical, LLC
SP-3025000385640000086 —On the market

Similar devices

Other devices filed under FDA product code CAF (Nebulizer (Direct Patient Interface)).

Other devices from Micromedics, Inc.

See all devices from Micromedics, Inc. →