Cleared Special

K082616 - HASELMEIER PEN 8

K082616 is an FDA 510(k) clearance for HASELMEIER PEN 8, manufactured by Haselmeier GmbH. The device is a Class 2 General Hospital device with product code FMF cleared through the Special 510(k) pathway after a 17-day FDA review.

K082616 · Haselmeier GmbH · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
17d
Days
Class 2
Risk

K082616 is an FDA 510(k) clearance for the HASELMEIER PEN 8. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Haselmeier GmbH (Farmington Hills, US). The FDA issued a Cleared decision on September 26, 2008 after a review of 17 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K082616

510(k) Number K082616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2008
Decision Date September 26, 2008
Days to Decision 17 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 129d · This submission: 17d
Pathway characteristics
Modification to existing cleared device.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FMF Syringe, Piston

All 634
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K082616.
SPECTRA-GLASS LOR (LOSS OF RESISTANCE SYRINGE, 5CC METAL L/S OR L/L TIP, SPECTRA-GLASS LOR (LOSS OF RESISTANCE) SYRINGE
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K081436 · Inviro Medical Devices, Inc. · Oct 2008
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K081241 · Shandong Weigao Group Medical Polymer Co., Ltd. · Sep 2008
BIO-MED SOFT INSULIN SYRINGE: MODELS 1CC, 0.5CC, 0.3CC
K081547 · Bio-Med USA, Inc. · Sep 2008
SPECTRA-LOR, 10 ML PLASTIC LOSS OF RESISTANCE SYRINGE, L/S, SPECTRA-LOR, 10ML PLASTIC LOSS OF RESISTANCE SYRINGE L/L
K081524 · Spectra Medical Devices, Inc. · Jul 2008
K082616 · HASELMEIER PEN 8
Download PDF FDA Summary Haselmeier GmbH