Atlas FDA

FZZ

23 FDA 510(k) clearances · Product code

52 daysmedian time to decision
140 days90th percentile
23clearances measured

FDA profile

Official device name
Marker, Skin
Device class
Class I (low risk)
Regulation
21 CFR 878.4660
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
2014: 6 · 2016: 19 · 2017: 24 · 2018: 21 · 2019: 18 · 2020: 14
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
SURGICHIP TAG SURGICAL MARKER (K042555)Surgichip, Inc.2004-11-09
DISPOSABLE SKIN MARKER (K915066)American Medical Mfg., Inc.1992-05-14
BLOOM TRANSPARENT STENCIL (K914759)Freckles Publications, Inc.1992-04-21
ROCKET SURGICAL SKIN MARKING PEN (K912730)West Texas Lighthouse For the Blind1991-11-07
SKIN MARKER (K905143)Aesculap, Inc.1991-02-06
QUALTEX SKIN MARKER (K904559)Qualtex, Inc.1990-12-13
SURGICAL SKIN MARKER (K896792)Westmark, Sterile Packing Systems, Inc. (Sps)1989-12-27
SURGICAL SKIN MARKER (K864371)Myocure, Inc.1986-11-17
DERMAMARKER (K863280)Dermacare Products, Inc.1986-09-09
LASER SKIN MARKER AND MASK WHITE LOTION (K861772)Pacific Poly Crafts1986-05-21
SECURLINE SURGICAL SKIN MARKER 1000 (K844865)Precision Dynamics Corp.1985-01-14
DISPOSABLE SKIN MARKING PEN (K843116)E.M. Adams1984-08-17
SCANLAN COLORMARK SKIN MARKER (K841085)Scanlan Intl., Inc.1984-06-11
SECURLINE SURGICAL SKIN MARKER 1000 (K840820)Precision Dynamics Corp.1984-04-25
SURGISCRIBE MARKING PEN (K840470)Surgicot, Inc.1984-03-12
TLS SURGICAL MARKER (K831372)Porex Medical1983-06-24
ACCU-LINE SURGICAL MARKER (K830298)Accu-Line1983-06-02
GLOMARK (K830703)Alphamedix, Inc.1983-04-28
SKIN MARKERS (K821063)Devon Industries, Inc.1982-06-25
SURGICAL RULER AND PEN (K790084)Devon Industries, Inc.1979-02-26
PEN, MARK-3 SKIN MARKING FOUNTAIN (K781694)Omega Mark-3 Pen Corp.1978-12-04
SKIN MARKING PEN (K781770)Abco Dealers, Inc.1978-11-15
SURGICAL MARKING PEN (K761323)Richard-Allan Medical Ind., Inc.1977-01-12

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Every clearance here is in the API, with alerts when new ones post.