Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart B — Diagnostic Devices](/submissions/AN/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 868.1100](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1100) → CBT — Arterial Blood Sampling Kit # CBT · Arterial Blood Sampling Kit _Anesthesiology · 21 CFR 868.1100 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBT ## Overview - **Product Code:** CBT - **Device Name:** Arterial Blood Sampling Kit - **Regulation:** [21 CFR 868.1100](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1100) - **Device Class:** 1 - **Review Panel:** [Anesthesiology](/submissions/AN) ## Identification An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations. The kit may include a syringe, needle, cork, and heparin. ## Classification Rationale Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. ## Recent Cleared Devices (20 of 58) Showing 20 most recent of 58 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K071269](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBT/K071269.md) | HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM | Smiths Medical Asd, Inc. | Aug 1, 2007 | SESE | | [K070340](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBT/K070340.md) | SECURE ARTERIAL BLOOD SAMPLING SYSTEM | Smiths Medical Asd, Inc. | Mar 15, 2007 | SESE | | [K955663](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBT/K955663.md) | ABC IN-LINE BLOOD SAMPLING KIT | Utah Medical Products, Inc. | Mar 17, 1997 | SESE | | [K954015](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBT/K954015.md) | ABG POINT LOK NEEDLE PROTECTION DEVICE | Devon Industries, Inc. | Nov 20, 1995 | SESE | | [K954035](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBT/K954035.md) | ACTI-FLEX ARTERIAL EXTENSION SET | R-Group Intl. | Sep 25, 1995 | SESE | | [K950098](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBT/K950098.md) | NEEDLE SAFETY COVER | Hammer-Plane, Inc. | Aug 11, 1995 | SESE | | [K945719](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBT/K945719.md) | ASPIR-PULSE(TM) ARTERIAL BLOOD GAS (ABG) SYSTEM | Sherwood Medical Co. | Mar 16, 1995 | SESK | | [K944941](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBT/K944941.md) | PISTON SYRINGE | Martell Medical Products, Inc. | Dec 5, 1994 | SESE | | [K945485](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBT/K945485.md) | ABG NEEDLE PROTECTION | Devon Industries, Inc. | Nov 29, 1994 | SESE | | [K940575](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBT/K940575.md) | ASPIR-PULSE(TM) SAF-T-VENT | Sherwood Medical Co. | Mar 22, 1994 | SESE | | [K931873](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBT/K931873.md) | VACVENT | Steven Frank Mercereau | Dec 30, 1993 | SEKD | | [K930986](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBT/K930986.md) | BLOOD GAS KIT (NON-STERILE) REORDER NO. 0560 | Customed, Inc. | Jul 14, 1993 | SEKD | | [K925453](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBT/K925453.md) | SHERWOOD MEDICAL ARTERIAL BLOOD GAS KIT I | Sherwood Medical Co. | Jul 12, 1993 | SEKD | | [K930471](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBT/K930471.md) | SHERWOOD MEDICAL ARTERIAL BLOOD GAS KIT II | Sherwood Medical Co. | Jun 22, 1993 | SEKD | | [K930286](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBT/K930286.md) | DRI-VENDT/PROVENT/ACCUVENT ARTERIAL BLOOD GAS KITS | Concord/Portex | Jun 22, 1993 | SEKD | | [K914778](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBT/K914778.md) | NEOLINE(TM) | Martech Medical Products, Inc. | Sep 16, 1992 | SESK | | [K912043](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBT/K912043.md) | ACCU-VENT(TM) WITH NEEDLE-PRO(TM) | Concord/Portex | Jul 5, 1991 | SEKD | | [K905464](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBT/K905464.md) | MEDICAL PROCEDURE KITS/ARTERIAL BLOOD SAMPLING | Angiosystems, Inc. | May 31, 1991 | SEKD | | [K902881](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBT/K902881.md) | LAB-SITE SAFETY NEEDLE | Migada, Ltd. | Sep 26, 1990 | SESE | | [K902632](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBT/K902632.md) | GAS-LYTE 1CC AND 3CC ARTERIAL BLOOD SAMPLERS | Marquest Medical Products, Inc. | Sep 4, 1990 | SESE | ## Top Applicants - Marquest Medical Products, Inc. — 8 clearances - Concord Laboratories, Inc. — 4 clearances - Sherwood Medical Co. — 4 clearances - Dhd Medical Products Div. Diemolding Corp. — 3 clearances - Emde Corp. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBT](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBT) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com