Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FZZ — Predicate Candidate Screening
23 FDA 510(k) clearances under this product code; the 50 most recent screened below.
52 daysmedian FDA review time
140 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K042555 | SURGICHIP TAG SURGICAL MARKER | Surgichip, Inc. | 2004-11-09 | 50 | 0 |
| K915066 | DISPOSABLE SKIN MARKER | American Medical Mfg., Inc. | 1992-05-14 | 188 | 0 |
| K914759 | BLOOM TRANSPARENT STENCIL | Freckles Publications, Inc. | 1992-04-21 | 182 | 0 |
| K912730 | ROCKET SURGICAL SKIN MARKING PEN | West Texas Lighthouse For the Blind | 1991-11-07 | 140 | 0 |
| K905143 | SKIN MARKER | Aesculap, Inc. | 1991-02-06 | 83 | 0 |
| K904559 | QUALTEX SKIN MARKER | Qualtex, Inc. | 1990-12-13 | 69 | 0 |
| K896792 | SURGICAL SKIN MARKER | Westmark, Sterile Packing Systems, Inc. (Sps) | 1989-12-27 | 26 | 0 |
| K864371 | SURGICAL SKIN MARKER | Myocure, Inc. | 1986-11-17 | 12 | 0 |
| K863280 | DERMAMARKER | Dermacare Products, Inc. | 1986-09-09 | 15 | 0 |
| K861772 | LASER SKIN MARKER AND MASK WHITE LOTION | Pacific Poly Crafts | 1986-05-21 | 14 | 0 |
| K844865 | SECURLINE SURGICAL SKIN MARKER 1000 | Precision Dynamics Corp. | 1985-01-14 | 31 | 0 |
| K843116 | DISPOSABLE SKIN MARKING PEN | E.M. Adams | 1984-08-17 | 9 | 0 |
| K841085 | SCANLAN COLORMARK SKIN MARKER | Scanlan Intl., Inc. | 1984-06-11 | 90 | 0 |
| K840820 | SECURLINE SURGICAL SKIN MARKER 1000 | Precision Dynamics Corp. | 1984-04-25 | 61 | 0 |
| K840470 | SURGISCRIBE MARKING PEN | Surgicot, Inc. | 1984-03-12 | 38 | 0 |
| K831372 | TLS SURGICAL MARKER | Porex Medical | 1983-06-24 | 58 | 0 |
| K830298 | ACCU-LINE SURGICAL MARKER | Accu-Line | 1983-06-02 | 125 | 0 |
| K830703 | GLOMARK | Alphamedix, Inc. | 1983-04-28 | 52 | 0 |
| K821063 | SKIN MARKERS | Devon Industries, Inc. | 1982-06-25 | 110 | 0 |
| K790084 | SURGICAL RULER AND PEN | Devon Industries, Inc. | 1979-02-26 | 41 | 0 |
| K781694 | PEN, MARK-3 SKIN MARKING FOUNTAIN | Omega Mark-3 Pen Corp. | 1978-12-04 | 55 | 0 |
| K781770 | SKIN MARKING PEN | Abco Dealers, Inc. | 1978-11-15 | 30 | 0 |
| K761323 | SURGICAL MARKING PEN | Richard-Allan Medical Ind., Inc. | 1977-01-12 | 16 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda