FDA product code KMN: Chair And Table, Medical

KMN is the FDA product code for chair and table, medical. It is a Class I device, regulated under 21 CFR 880.6140 and reviewed by the General Hospital panel. FDA has cleared 3 510(k) submissions under KMN, from 3 different applicants. The average 510(k) review took 23 days (median 15). FDA has posted 3 recalls for KMN devices.

Classification

FieldValue
Device nameChair And Table, Medical
Device classClass I
Regulation21 CFR 880.6140
Review panelHO — General Hospital
Medical specialtyGeneral Hospital
Premarket route510(k) exempt
GMP exemptYes

Compare with all 510(k) review times · Search every KMN clearance

Top KMN applicants

ApplicantClearancesLatest
M.D. Intl., Inc.11989-09-08
Volunteer Blind Industries, Inc.11980-08-27
Fred Sammons, Inc.11976-12-02

Most recent KMN clearances

510(k)ApplicantDeviceDecision dateReview days
K894788M.D. Intl., Inc.DMI SERIES 90 EXAMINATION TABLE1989-09-0842
K801936Volunteer Blind Industries, Inc.PAD, EXAMINING TABLE1980-08-2715
K761110Fred Sammons, Inc.BED TRAY1976-12-0213

Recalls for KMN devices

3 product recalls in 2 recall events; 0 initiated in the last five years and 2 still open. Most recent: 2021-05-12.

YearRecalls
20212

Frequently asked questions

What is FDA product code KMN?

KMN is the FDA product code for chair and table, medical. It is a Class I device, regulated under 21 CFR 880.6140 and reviewed by the General Hospital panel.

What device class is KMN?

Class I, regulation 21 CFR 880.6140. Typical premarket route: 510(k) exempt.

How long does a 510(k) take for product code KMN?

Across 3 cleared submissions the average was 23 days from receipt to decision (median 15).

Which companies have the most KMN clearances?

M.D. Intl., Inc. (1); Volunteer Blind Industries, Inc. (1); Fred Sammons, Inc. (1).

Have KMN devices been recalled?

Yes: 3 product recalls across 2 recall events; the most recent began 2021-05-12.

Next steps

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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