FDA product code KLK: Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
KLK is the FDA product code for monitor, oxygen, cutaneous, for infant not under gas anesthesia. It is a Class II device, regulated under 21 CFR 868.2500 and reviewed by the Anesthesiology panel. FDA has cleared 47 510(k) submissions under KLK, from 26 different applicants. The average 510(k) review took 123 days (median 60). FDA has posted 3 recalls for KLK devices.
Classification
| Field | Value |
|---|---|
| Device name | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia |
| Device class | Class II |
| Regulation | 21 CFR 868.2500 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KLK clearance
Top KLK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Novametrix Medical Systems, Inc. | 13 | 1987-05-27 |
| Biochem International, Inc. | 3 | 1984-04-17 |
| Linde Medical Sensors AG | 2 | 2001-05-04 |
| Hewlett-Packard Co. | 2 | 1993-07-29 |
| Mennen Medical, Inc. | 2 | 1989-07-14 |
21 more applicants have KLK clearances. See the full list in Caduvo.
Most recent KLK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K003943 | Linde Medical Sensors AG | MICROGAS 7650 TRANSCUTANEOUS MONITOR | 2001-05-04 | 134 |
| K991644 | Linde Medical Sensors AG | MICROGAS 7650 TRANSCUTANEOUS MONITOR | 1999-05-21 | 8 |
| K980287 | Siemens Medical Solutions USA, Inc. | SIEMENS SC9000/SC9015 TCP02/C02 MODULE | 1998-08-12 | 198 |
| K924709 | Air-Shields, Inc. | SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE | 1996-01-17 | 1216 |
| K924679 | Air-Shields Vickers, Inc. | OXYCARE(TM) OXYGEN CONTROLLER/MONITOR | 1995-02-21 | 888 |
Recalls for KLK devices
3 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2006-04-07.
Frequently asked questions
What is FDA product code KLK?
KLK is the FDA product code for monitor, oxygen, cutaneous, for infant not under gas anesthesia. It is a Class II device, regulated under 21 CFR 868.2500 and reviewed by the Anesthesiology panel.
What device class is KLK?
Class II, regulation 21 CFR 868.2500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KLK?
Across 47 cleared submissions the average was 123 days from receipt to decision (median 60).
Which companies have the most KLK clearances?
Novametrix Medical Systems, Inc. (13); Biochem International, Inc. (3); Linde Medical Sensors AG (2); Hewlett-Packard Co. (2); Mennen Medical, Inc. (2).
Have KLK devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2006-04-07.
Next steps
- Run an FDA pathway report with predicate devices for product code KLK
- Run a recall and safety report across every KLK manufacturer
- Watch product code KLK 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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