DORO HEADREST SYSTEM— 510(k) K001808
Substantially EquivalentPro-Med Instruments GmbH
FDA 510(k) clearance K001808 for DORO HEADREST SYSTEM, Substantially Equivalent on 2000-08-04. Applicant: Pro-Med Instruments GmbH. Device class: 2.
Clearance details
- Applicant
- Pro-Med Instruments GmbH
- Product code
- Code HBL
- Device class
- Class 2
- Regulation
- 21 CFR 882.4460
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Roswell, GA, US
Recent devices under product code HBL
view all- K250423 — mb-FIX Cranial Stabilization Systems
- K241883 — DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00) +4 more
- K240319 — DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)
- K203505 — DORO QR3 Headrest System (Aluminum)
- K193438 — DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)
More clearances from Pro-Med Instruments GmbH
view all- K191740 — DORO LUCENT® iXI and iMRI Headrest System
- K191979 — DORO QR3 XTom Headholder System
- K063494 — DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTS
- K070997 — DORO NON-STICK BIPOLAR FORCEPS, MODEL 5001-XX TO 5012-XX, DORO BIPOLAR REUSABLE CABLES, MODEL 5015-XX
- K032331 — DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT J-ARM RETRACTOR SYSTEM (ALUMINUM ALLOY)
Adverse events under product code HBL
product code HBL- Death
- 3
- Injury
- 753
- Malfunction
- 1,421
- Total
- 2,177
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K001808
K-number listed on FDA's recall record- Z-1860-2025 — DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)
- Z-0193-2018 — pmi, pro med instruments, DORO(R) Sterile Disposable Skull Pins, 3 pieces (3 pieces per blister, 12 blisters per box), STERILE R, Rx ONLY The DORO(R) Skull Pins are inserted into the receptacles of the skull clamp and fixate the head during surgery.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K001808.
Data sourced from openFDA. This site is unofficial and independent of the FDA.