Sims Adult Lumbar Puncture Kit (4800-20, 4801-20, 4806-22, 4807-22)

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K963570 ↗

FDA Product Code

FMJ

Device Class

Class II

Regulation

21 CFR Part 880.2500

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Percutaneous Tracheostomy Kit

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  FDA 510(k) K936133 Active Cleared 23 Mar 1994

• Pro-Vent(Tm), Pulsator(R), and Line Draw(Tm) Arterial Blood Sampling Syringes

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  FDA 510(k) K945777 Active Cleared 22 Dec 1994

• Sims Cpap System

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  FDA 510(k) K953485 Active Cleared 26 Oct 1995

• Regional Anesthesia Trays Open recall

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  FDA 510(k) K965017 Active Cleared 14 Mar 1997

• Fenestrated Flexible D.I.C. Tracheostomy Tube Cuffed

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  FDA 510(k) K972385 Active Cleared 20 Jan 1998

• Pro-Vent, Line Draw, Pulsator Open recall

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  FDA 510(k) K952516 Active Cleared 14 Jul 1995

See all devices from Smiths Industries Medical Systems, Inc. →

• What types of procedures is the Sims Adult Lumbar Puncture Kit designed for, and how does it differ from other spinal-fluid manometers?

  The Sims Adult Lumbar Puncture Kit is specifically designed for diagnostic and therapeutic lumbar puncture procedures in adult patients. Unlike some other spinal-fluid manometers, this kit includes components for accessing cerebrospinal fluid, measuring pressure, and collecting samples under sterile conditions—all essential for accurate diagnostics and treatment guidance. It is tailored for hospital use and is classified as a Class II device, indicating it undergoes stricter regulatory oversight to ensure safety and effectiveness.

• Are there different versions of this kit, and if so, what do the reference codes (e.g., 4800-20, 4806-22) indicate?

  Yes, the kit is available in multiple configurations, as indicated by the reference codes (e.g., 4800-20, 4801-20, 4806-22, 4807-22). These codes likely correspond to variations in components or procedural needs, such as different needle sizes, pressure measurement scales, or additional accessories for specific clinical scenarios. The manufacturer provides these options to accommodate different procedural requirements while maintaining the core function of lumbar puncture.

• Is this kit intended for reuse, or is it meant for single-use only? How does that affect its sterility and handling?

  The Sims Adult Lumbar Puncture Kit is explicitly intended for single-use only, as stated in the manufacturer’s description. This design ensures sterility and safety for each procedure, reducing the risk of contamination or cross-infection. Single-use kits also eliminate the need for reprocessing, simplifying workflow in hospital settings while maintaining compliance with sterile technique requirements for lumbar punctures.

• What regulatory pathway was followed for this device, and how does that impact its use in clinical settings?

  The kit was cleared through the FDA’s 510(k) Traditional pathway, with a Substantially Equivalent (SESE) determination under the General Hospital advisory committee category. This means the device was compared to a legally marketed predicate and deemed equivalent in safety and effectiveness. Clinically, this clearance ensures the kit meets FDA standards for spinal-fluid manometers, allowing hospitals to rely on its performance for diagnostic and therapeutic lumbar punctures while adhering to regulatory compliance.