FDA product code LHC: Warmer, Irrigation Solution
LHC is the FDA product code for warmer, irrigation solution. It is a Class I device, regulated under 21 CFR 890.5950 and reviewed by the General Hospital panel. FDA has cleared 24 510(k) submissions under LHC, from 17 different applicants. The average 510(k) review took 113 days (median 68). FDA has posted 10 recalls for LHC devices.
Classification
| Field | Value |
|---|---|
| Device name | Warmer, Irrigation Solution |
| Device class | Class I |
| Regulation | 21 CFR 890.5950 |
| Review panel | HO — General Hospital |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LHC clearance
Top LHC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ecolab, Inc. | 4 | 2016-01-15 |
| O.R. Solutions, Inc. | 4 | 2002-11-13 |
| C Change Surgical, LLC | 2 | 2009-01-13 |
| Getinge Sourcing, LLC | 1 | 2016-06-07 |
| Mac Medical | 1 | 2008-06-13 |
12 more applicants have LHC clearances. See the full list in Caduvo.
Most recent LHC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K153713 | Getinge Sourcing, LLC | Getinge Series Warming Cabinet | 2016-06-07 | 166 |
| K152522 | Ecolab, Inc. | ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes | 2016-01-15 | 134 |
| K150190 | Ecolab, Inc. | IntraTemp Solution Warmer | 2015-02-26 | 30 |
| K142173 | Ecolab, Inc. | NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE | 2014-12-30 | 145 |
| K142080 | Ecolab, Inc. | NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED | 2014-08-28 | 28 |
Recalls for LHC devices
10 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-10-25.
Frequently asked questions
What is FDA product code LHC?
LHC is the FDA product code for warmer, irrigation solution. It is a Class I device, regulated under 21 CFR 890.5950 and reviewed by the General Hospital panel.
What device class is LHC?
Class I, regulation 21 CFR 890.5950. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LHC?
Across 24 cleared submissions the average was 113 days from receipt to decision (median 68).
Which companies have the most LHC clearances?
Ecolab, Inc. (4); O.R. Solutions, Inc. (4); C Change Surgical, LLC (2); Getinge Sourcing, LLC (1); Mac Medical (1).
Have LHC devices been recalled?
Yes: 10 product recalls across 3 recall events; the most recent began 2016-10-25.
Next steps
- Run an FDA pathway report with predicate devices for product code LHC
- Run a recall and safety report across every LHC manufacturer
- Watch product code LHC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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