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Medical device manufacturer

Hollister Incorporated

Hollister Incorporated holds 100 FDA 510(k) clearances across 28 product codes. Median elapsed review time is 78 days. openFDA lists 5 recall records naming the company. FDA publishes it under 6 different spellings, all counted here as one company.

Updated · ingest status · JSON

510(k) clearances
100
Product codes
28
Median review
78 days
Recall records
5

How does FDA spell Hollister Incorporated?

FDA publishes this company under 6 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.

Every spelling FDA published for this company, and which dataset each came from.
As FDA published itDatasetMatched by
HOLLISTER INCORPORATEDdevice/registrationlistingnormalised
HOLLISTER, INC.device/registrationlistingnormalised
Hollister Incorporateddevice/recallnormalised
Hollister Incorporateddevice/enforcementnormalised
Hollister Incorporateddevice/510knormalised
Hollister, Inc.device/510knormalised

Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.

Which product codes does Hollister Incorporated file in?

28 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
EXBCollector, Ostomy1424 days
GBMCatheter, Urethral1130 days
KPIStimulator, Electrical, Non-Implantable, For Incontinence1060 days
ILOPack, Hot Or Cold, Water Circulating785 days
KNTTubes, Gastrointestinal (And Accessories)7103 days
FRODressing, Wound, Drug628 days
EZDCatheter, Straight5231 days
FMQRestraint, Protective478 days
HIRPerineometer4119 days
KNXCollector, Urine, (And Accessories) For Indwelling Catheter415 days
EXIDevice, Paste-On For Incontinence, Sterile220 days
EXJDevice, Incontinence, Urosheath Type, Sterile253 days
FMZIncubator, Neonatal2140 days
HDBExtractor, Vacuum, Fetal2158 days
HFWClamp, Umbilical235 days
HGYPump, Breast, Non-Powered290 days
KODCatheter, Urological287 days
KOZBeads, Hydrophilic, For Wound Exudate Absorption291 days
MGPDressing, Wound And Burn, Occlusive231 days
FOCBag, Urine Collection, Newborn121 days
FONBag, Drainage, With Adhesive, Ostomy146 days
GBXCatheter, Irrigation159 days
HGXPump, Breast, Powered1227 days
JDYEvacuator, Vapor, Cement Monomer1176 days
KICCushion, Flotation120 days

Showing the 25 they file in most, of 28.

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 Hollister Incorporated had a recall?

openFDA lists 5 recall records naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.

  • Z-1178-2025Class IIOpen, ClassifiedCBH

    Hollister received reports of decreased skin barrier wear time which could can lead to tube migration

  • Z-1179-2025Class IIOpen, ClassifiedCBH

    Hollister received reports of decreased skin barrier wear time which could can lead to tube migration

  • Z-1180-2025Class IIOpen, ClassifiedCBH

    Hollister received reports of decreased skin barrier wear time which could can lead to tube migration

  • Z-1181-2025Class IIOpen, ClassifiedCBH

    Hollister received reports of decreased skin barrier wear time which could can lead to tube migration

  • Z-1311-2021Class IITerminatedKNT

    The tube holder can separate from the barrier that secures the device to the patients' body. The tube holder has the potential failure to separate from the barrier. This separation might contribute to the potential risk of the tube/drain/catheter migration or loss.

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 Hollister Incorporated cleared recently?

Most recent 510(k) clearances for this company, newest first.
510(k)DeviceCodeDecisionElapsed days
K253295Coude Sleeved IC; Coude Plus Sleeved ICEZD231
K251468Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (name not finalized) Sleeved IC 3 Plus Pocket (name not finalized) (N/A)EZD143
K233524Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket (Name not Finalized); Sleeved IC 2 Plus Pocket (Name not Finalized)EZD184
K220667Sleeved ICEZD276
K213575Female IC (Not Finalized)EZD307
K211436Intermittent Catheter (Not Finalized)GBM262
K193148VaPro Plus Pocket, VaPro PlusGBM30
K191633Infyna ChicGBM30
K183253ValPro 2 Plus, VaPro 2 Plus PocketGBM27
K180824VaPro 2 Intermittent CatheterGBM84

Source: openFDA device/510k · retrieved

Where is Hollister Incorporated registered?

FDA lists 3 registered establishments for this company in US.

Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.

Watch what Hollister Incorporated 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.