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Medical device manufacturer

Fred Sammons, Inc.

Fred Sammons, Inc. holds 278 FDA 510(k) clearances across 56 product codes. Median elapsed review time is 17 days. openFDA lists no recall records naming the company.

Updated · ingest status · JSON

510(k) clearances
278
Product codes
56
Median review
17 days
Recall records
0

How does FDA spell Fred Sammons, Inc.?

FDA publishes this company under a single spelling, so nothing needed merging here. Many manufacturers are not so tidy.

Which product codes does Fred Sammons, Inc. file in?

56 product codes, ranked by how much they file in each.

Product codes this company holds clearances in, with their median elapsed review time in each.
CodeDeviceClearancesMedian reviewLatest
ILCUtensil, Eating2817 days
KNOAccessories, Wheelchair2517 days
ILHSplint, Hand, And Components2118 days
ILPSystem, Communication, Non-Powered1816 days
IONExerciser, Non-Measuring1816 days
ILSAdaptor, Hygiene1713 days
ILDAdaptor, Dressing1417 days
IKWUtensil, Homemaking1221 days
IKXAid, Transfer821 days
KQWGoniometer, Nonpowered811 days
ILTAdaptor, Recreational746 days
ILWAdaptor, Grooming717 days
IODComponents, Exercise721 days
IQIOrthosis, Limb Brace714 days
HRWDynamometer, Nonpowered69 days
IROVibrator, Therapeutic513 days
IMEPack, Hot Or Cold, Reusable413 days
KNNComponents, Wheelchair424 days
ILISling, Arm324 days
KNXCollector, Urine, (And Accessories) For Indwelling Catheter320 days
FMPProtector, Skin Pressure224 days
GWXFork, Tuning213 days
GXBEsthesiometer210 days
INNChair, Adjustable, Mechanical221 days
IPTOrthosis, Thoracic28 days

Showing the 25 they file in most, of 56.

Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.

Source: openFDA device/510k · retrieved

Has Fred Sammons, Inc. had a recall?

openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.

Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.

Source: openFDA device/recall · retrieved

What has Fred Sammons, Inc. cleared recently?

Most recent 510(k) clearances for this company, newest first.
510(k)DeviceCodeDecisionElapsed days
K880644ULTRA-PAN FOR ORTHOTIC PLASTICS (7262)IRQ80
K880647ADULT PERCEPTUAL MOTOR PUZZLES (5331-01)HOX45
K831549ARM SLINGSILI49
K831548SPLINTSILH46
K831550FINGER BONIOMETER BK7506KQW43
K831544DELUXE TRACTION EXERCISE GLOVE BK5035IOD43
K831543ADJUST. WEIGHTS-BK5171-05,10,20 BEOKION43
K831542ADJUSTABLE POLYCENTRIC ELBOW HINGEIQI43
K831553LEG DRAINAGE BAG STRAP BK6011KNX35
K831552SORBOTHANE VISCO INNER SOLE PADKNP27

Source: openFDA device/510k · retrieved

Watch what Fred Sammons, Inc. files next

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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.