Data / Medical devices / United States / Katmai Integrated Solutions
Katmai Integrated Solutions: FDA-registered device maker in Brilliant, OH, United States, 58 510(k) clearances
Katmai Integrated Solutions is registered with the FDA (registration 3015997711) in Brilliant, OH, United States. It lists 61 device types. The FDA files 58 510(k) clearances under its listings, the newest dated October 8, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015997711
- Address
- 34 Kelley Way, Brilliant, OH, United States, 43913
- Owner or operator
- Katmai Health Services, LLC (10050389)
- Roles
- Repackager or relabeler
- First device listed
- November 11, 2015
- Registered through
- 2026
- Brand names listed
- ADC DIAGNOSTIX 700 SERIES / ADC DIAGNOSTIX 700 SERIES BP CUFF, BLACK, ADULT, LATEX FREE, ADHESIVE TAPE, COMBAT MEDIC, REINFORCED, 2" x 100", ADTEMP II 413 DIGITAL THERMOMETERS AND COVERS / ADC ADTEMP DIGITAL THERMOMETER SHEATHS, ADTEMP 419 HYPOTHERMIA THERMOMETERS / ADC ADTEMP DIGITAL HYPOTHERMIA THERMOMETER, AIRWAY KIT, ORAL, Six Piece Set, AIRWAY KIT, SUPRAGLOTTIC, Size 4, AIRWAY KIT, SUPRAGLOTTIC, Size 5, BAG,URINE COLLECTION 2 Liters and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 8, 2015 | K150711 | Salem Sump Dual Lumen Stomach Tube with Multi-functional Port | PIF | Substantially Equivalent | Covidien | accessdata.fda.gov |
| September 30, 2015 | K142928 | FreeStyle Precision Neo Blood Glucose Monitoring System | NBW | Substantially Equivalent | Abbott Diabetes Care, Inc. | accessdata.fda.gov |
| July 24, 2015 | K143082 | IV Administration Sets with 200(micro)m Blood Filter | FPA | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| January 15, 2015 | K142622 | IV Administration | FPA | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| August 29, 2014 | K142097 | SELEC-3 I.V.ADMINISTRATION SET | FPA | Substantially Equivalent | Biomedix, Inc. | accessdata.fda.gov |
| August 14, 2014 | K133973 | TEMPUS PRO WITH ENHANCED FEATURES | QYW | Substantially Equivalent | Remote Diagnostic Technologies , Ltd. | accessdata.fda.gov |
| July 11, 2013 | K123881 | HEARTSINE SAMARITAN PAD 350P | MKJ | Substantially Equivalent | Heartsine Technologies, Inc. | accessdata.fda.gov |
| June 30, 2011 | K102177 | SENSICARE POWDER-FREE POLYMER COATED POLYSOPRENE SURGICAL GLOVES, STERILE | KGO | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| February 10, 2011 | K103553 | LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTION | JJX | Substantially Equivalent | Bionostics, Inc. | accessdata.fda.gov |
| December 22, 2010 | K102350 | PULSE OXIMETER | DQA | Substantially Equivalent | Nonin Medical, Inc. | accessdata.fda.gov |
| September 8, 2010 | K102032 | KIMBERLY-CLARK PURPLE NITRILE XTRA* STERILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) - 12 STERILE PAIRS | LZA | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| July 29, 2010 | K100654 | ZOLL PROPAQ MD | LDD | Substantially Equivalent | Zoll Medical Corporation, World Wide Headquarters | accessdata.fda.gov |
| February 5, 2010 | K093081 | POCKET BVM | BTM | Substantially Equivalent | Microbvm Systems , Ltd. | accessdata.fda.gov |
| October 14, 2009 | K091140 | EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION SYSTEM, EZ-IO | FMI | Substantially Equivalent | Vidacare Corporation | accessdata.fda.gov |
| October 2, 2009 | K092058 | SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Sonosite,Inc. | accessdata.fda.gov |
| September 17, 2008 | K082362 | SURSHIELD SAFETY I.V. CATHETER | FOZ | Substantially Equivalent | Terumo Medical Corp. | accessdata.fda.gov |
| September 12, 2008 | K081569 | DYNAREX/TILLOTSON NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAM GLOVE FOR USE WITH CHEMOTHERAPY DRUGS | LZA | Substantially Equivalent | Dynarex Corporation | accessdata.fda.gov |
| July 9, 2008 | K081260 | KIMBERLY-CLARK *LAVENDER* NITRILE POWER-FREE EXAM GLOVES | LZA | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| April 24, 2008 | K080865 | FAST1 INTRAOSSEOUS INFUSION SYSTEM | FMI | Substantially Equivalent | Pyng Medical Corp. | accessdata.fda.gov |
| February 8, 2008 | K073188 | HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE | FMI | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| September 6, 2007 | K071221 | SAVE-SIMPLIFIED AUTOMATED VENTILATOR, MODELS: 550X10, 600X10 AND 600X12 | BTL | Substantially Equivalent | Automedx, Inc. | accessdata.fda.gov |
| May 8, 2007 | DEN060009 | 3M N95 HOME RESPIRATOR WITH FLUID RESISTANCE; 3M N95 HOME RESPIRATOR | NZJ | Unknown | 3M Company | accessdata.fda.gov |
| August 10, 2006 | K061086 | DM-3000 DIGITAL BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | Nihon Seimitsu Sokki Co., Ltd. | accessdata.fda.gov |
| May 19, 2006 | K061118 | ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Lifescan, Inc. | accessdata.fda.gov |
| May 4, 2004 | K033189 | KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305 | CAE | Substantially Equivalent | King Systems Corp. | accessdata.fda.gov |
| April 14, 2004 | K033186 | KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205 | CAE | Substantially Equivalent | King Systems Corp. | accessdata.fda.gov |
| March 22, 2004 | K040159 | APM BLOOD PRESSURE MONITOR, MODEL BP108A | DXN | Substantially Equivalent | Asia Pacific Microsystems, Inc. | accessdata.fda.gov |
| October 1, 2002 | K014071 | PMX DISPOSABLE BAG MASK RESUSCITATOR | BTM | Substantially Equivalent | Allied Healthcare Products, Inc. | accessdata.fda.gov |
| July 19, 2002 | K021475 | BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET | FMI | Substantially Equivalent | Bd | accessdata.fda.gov |
| August 7, 2000 | K002134 | ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM | CGA | Substantially Equivalent | Selfcare, Inc. | accessdata.fda.gov |
| January 16, 1998 | K974768 | PDI STERILE LUBRICATING JELLY | KMJ | Substantially Equivalent | Nice-Pak Products, Inc. | accessdata.fda.gov |
| December 16, 1997 | K963659 | EXEL I.V. ADMINISTRATION SET | FPA | Substantially Equivalent | Exel Intl. | accessdata.fda.gov |
| January 27, 1997 | K962655 | ANEROID AND MERCURIAL SPHYGMOMANOMETERS | DXQ | Substantially Equivalent | American Diagnostic Corp. | accessdata.fda.gov |
| June 27, 1996 | K955495 | RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILE | BTR | Substantially Equivalent | Rusch, Inc. | accessdata.fda.gov |
| November 27, 1995 | K953797 | SHARPS DISPOSAL CONTAINERS | MMK | Substantially Equivalent | Bemis Mfg. Co. | accessdata.fda.gov |
| March 21, 1995 | K945806 | SILICATH ALL SILICONE FOLEY CATHETER | EZL | Substantially Equivalent | Unomedical Sdn Bhd | accessdata.fda.gov |
| September 27, 1994 | K944400 | PEDI-CAP | CCK | Substantially Equivalent | Nellcor, Inc. | accessdata.fda.gov |
| July 8, 1994 | K940686 | ELECTRONIC THERMOMETERS | FLL | Substantially Equivalent | American Diagnostic Corp. | accessdata.fda.gov |
| May 26, 1994 | K941562 | 1ML LUER-LOK SYRINGE | FMF | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| May 10, 1994 | K940918 | I-STAT 200 PORTABLE CLINICAL ANALYZER | CHL | Substantially Equivalent | I-Stat Corp. | accessdata.fda.gov |
| March 3, 1994 | K935944 | PROSCOPES AND ADSCOPES | LDE | Substantially Equivalent | American Diagnostic Corp. | accessdata.fda.gov |
| January 28, 1994 | K936134 | BERMAN AIRWAY | CAE | Substantially Equivalent | Smiths Industries Medical Systems, Inc. | accessdata.fda.gov |
| December 27, 1993 | K932422 | 3M TEGADERM HP TRANSPARENT DRESSING | KGX | Substantially Equivalent | 3M Health Care, Ltd. | accessdata.fda.gov |
| December 2, 1993 | K933048 | LAERDAL(TM) POCKET MASK, MODIFICATION | KGB | Substantially Equivalent | Laerdal Medical Corp. | accessdata.fda.gov |
| December 17, 1992 | K924072 | BECTON DICKINSON SAFETY-LOK SYRINGE | FMF | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| July 10, 1992 | K914743 | EMERGENCY PERCUTANEOUS CRICOTHYROIDOTOMY KIT,MODIF | BTO | Substantially Equivalent | Pertrach | accessdata.fda.gov |
| January 17, 1992 | K914760 | LATEX EXAMINATION GLOVES | LYY | Substantially Equivalent | Ansell, Inc. | accessdata.fda.gov |
| January 26, 1990 | K894686 | POWDER-FREE VINYL EXAMINATION GLOVES | LYY | Substantially Equivalent | Dynarex Corp. | accessdata.fda.gov |
| November 27, 1989 | K896072 | D.L. SCOPE OPHTHALMOSCOPE | HLJ | Substantially Equivalent | North American Medical Products, Inc. | accessdata.fda.gov |
| May 9, 1988 | K881618 | ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK | FXX | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| April 23, 1986 | K861153 | DISPOSABLE SYRINGES AND HYPODERMIC NEEDLES | FMF | Substantially Equivalent | Exel Intl. | accessdata.fda.gov |
| October 4, 1983 | K831931 | ATRIUM THORACIC CATHETER | GBZ | Substantially Equivalent | Atrium Medical Corp. | accessdata.fda.gov |
| January 18, 1983 | K830047 | FIBER OPTIC LARYNGOSCOPES W/BATTERY | CCW | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| July 14, 1982 | K821909 | LITTMAN TUNABLE STETHOSCOPE 2136 | LDE | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| April 1, 1982 | K820717 | MONOJECT CORVAC STAT VAC TUBE W/THROM | JKA | Substantially Equivalent | Sherwood Medical Co. | accessdata.fda.gov |
| September 26, 1980 | K802242 | 3M HI-STRENGTH MED. TAPE #1534 | KGX | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| July 14, 1977 | K771205 | HYPODERMIC SYRINGE | FMF | Substantially Equivalent | Terumo America, Inc. | accessdata.fda.gov |
| July 16, 1976 | K760094 | SPONGE, CURITY WASHED GAUZE | NAB | Substantially Equivalent | Kendall Research Center | accessdata.fda.gov |
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Updated October 8, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.