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Pulmosal

by Pharmacaribe

510(k) K130091

Pulmosal is a medical device (FDA Class II; FDA product code CAF, Nebulizer (Direct Patient Interface)) made by Pharmacaribe, cleared under FDA 510(k) K130091 on 13 Mar 2013, active as of 22 Oct 2026. One FDA recall is linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 · Special NumberK130091 Date13 Mar 2013ClearedStatusActive

Official records

Recalls

1 recall · FDA

    • Terminated Z-0795-2016 FDA Class II initiated 29 Dec 2015

    Vials were labeled as USP 7% Hypertonic saline instead of PulmoSal 7% (pH+)

Timeline

2 dated events

  1. Cleared FDA 510(k) K130091
  2. Recall initiated FDA recalls Z-0795-2016

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  • Withdrawn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

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 K130091

1 device · 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 K130091
UDI-DISize and differences
PulmoSal 7% (pH+) 74060
PHARMACARIBE, LLC.
50190-740-60 / 7406040850877007033
Total Volume 4 mL
On the market

Similar devices

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

Other devices from Pharmacaribe LLC